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. 2022 Jan 28;1(1):CD013334.
doi: 10.1002/14651858.CD013334.pub2.

Low-carbohydrate versus balanced-carbohydrate diets for reducing weight and cardiovascular risk

Celeste E Naude  1 , Amanda Brand  1 , Anel Schoonees  1 , Kim A Nguyen  1 , Marty Chaplin  2 , Jimmy Volmink  1
Affiliations

Low-carbohydrate versus balanced-carbohydrate diets for reducing weight and cardiovascular risk

Celeste E Naude et al. Cochrane Database Syst Rev. .

Abstract

Background: Debates on effective and safe diets for managing obesity in adults are ongoing. Low-carbohydrate weight-reducing diets (also known as 'low-carb diets') continue to be widely promoted, marketed and commercialised as being more effective for weight loss, and healthier, than 'balanced'-carbohydrate weight-reducing diets.

Objectives: To compare the effects of low-carbohydrate weight-reducing diets to weight-reducing diets with balanced ranges of carbohydrates, in relation to changes in weight and cardiovascular risk, in overweight and obese adults without and with type 2 diabetes mellitus (T2DM).

Search methods: We searched MEDLINE (PubMed), Embase (Ovid), the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection (Clarivate Analytics), ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) up to 25 June 2021, and screened reference lists of included trials and relevant systematic reviews. Language or publication restrictions were not applied.

Selection criteria: We included randomised controlled trials (RCTs) in adults (18 years+) who were overweight or living with obesity, without or with T2DM, and without or with cardiovascular conditions or risk factors. Trials had to compare low-carbohydrate weight-reducing diets to balanced-carbohydrate (45% to 65% of total energy (TE)) weight-reducing diets, have a weight-reducing phase of 2 weeks or longer and be explicitly implemented for the primary purpose of reducing weight, with or without advice to restrict energy intake. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts and full-text articles to determine eligibility; and independently extracted data, assessed risk of bias using RoB 2 and assessed the certainty of the evidence using GRADE. We stratified analyses by participants without and with T2DM, and by diets with weight-reducing phases only and those with weight-reducing phases followed by weight-maintenance phases. Primary outcomes were change in body weight (kg) and the number of participants per group with weight loss of at least 5%, assessed at short- (three months to < 12 months) and long-term (≥ 12 months) follow-up.

Main results: We included 61 parallel-arm RCTs that randomised 6925 participants to either low-carbohydrate or balanced-carbohydrate weight-reducing diets. All trials were conducted in high-income countries except for one in China. Most participants (n = 5118 randomised) did not have T2DM. Mean baseline weight across trials was 95 kg (range 66 to 132 kg). Participants with T2DM were older (mean 57 years, range 50 to 65) than those without T2DM (mean 45 years, range 22 to 62). Most trials included men and women (42/61; 3/19 men only; 16/19 women only), and people without baseline cardiovascular conditions, risk factors or events (36/61). Mean baseline diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol across trials were within normal ranges. The longest weight-reducing phase of diets was two years in participants without and with T2DM. Evidence from studies with weight-reducing phases followed by weight-maintenance phases was limited. Most trials investigated low-carbohydrate diets (> 50 g to 150 g per day or < 45% of TE; n = 42), followed by very low (≤ 50 g per day or < 10% of TE; n = 14), and then incremental increases from very low to low (n = 5). The most common diets compared were low-carbohydrate, balanced-fat (20 to 35% of TE) and high-protein (> 20% of TE) treatment diets versus control diets balanced for the three macronutrients (24/61). In most trials (45/61) the energy prescription or approach used to restrict energy intake was similar in both groups. We assessed the overall risk of bias of outcomes across trials as predominantly high, mostly from bias due to missing outcome data. Using GRADE, we assessed the certainty of evidence as moderate to very low across outcomes. Participants without and with T2DM lost weight when following weight-reducing phases of both diets at the short (range: 12.2 to 0.33 kg) and long term (range: 13.1 to 1.7 kg). In overweight and obese participants without T2DM: low-carbohydrate weight-reducing diets compared to balanced-carbohydrate weight-reducing diets (weight-reducing phases only) probably result in little to no difference in change in body weight over three to 8.5 months (mean difference (MD) -1.07 kg, (95% confidence interval (CI) -1.55 to -0.59, I2 = 51%, 3286 participants, 37 RCTs, moderate-certainty evidence) and over one to two years (MD -0.93 kg, 95% CI -1.81 to -0.04, I2 = 40%, 1805 participants, 14 RCTs, moderate-certainty evidence); as well as change in DBP and LDL cholesterol over one to two years. The evidence is very uncertain about whether there is a difference in the number of participants per group with weight loss of at least 5% at one year (risk ratio (RR) 1.11, 95% CI 0.94 to 1.31, I2 = 17%, 137 participants, 2 RCTs, very low-certainty evidence). In overweight and obese participants with T2DM: low-carbohydrate weight-reducing diets compared to balanced-carbohydrate weight-reducing diets (weight-reducing phases only) probably result in little to no difference in change in body weight over three to six months (MD -1.26 kg, 95% CI -2.44 to -0.09, I2 = 47%, 1114 participants, 14 RCTs, moderate-certainty evidence) and over one to two years (MD -0.33 kg, 95% CI -2.13 to 1.46, I2 = 10%, 813 participants, 7 RCTs, moderate-certainty evidence); as well in change in DBP, HbA1c and LDL cholesterol over 1 to 2 years. The evidence is very uncertain about whether there is a difference in the number of participants per group with weight loss of at least 5% at one to two years (RR 0.90, 95% CI 0.68 to 1.20, I2 = 0%, 106 participants, 2 RCTs, very low-certainty evidence). Evidence on participant-reported adverse effects was limited, and we could not draw any conclusions about these. AUTHORS' CONCLUSIONS: There is probably little to no difference in weight reduction and changes in cardiovascular risk factors up to two years' follow-up, when overweight and obese participants without and with T2DM are randomised to either low-carbohydrate or balanced-carbohydrate weight-reducing diets.

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Conflict of interest statement

CN: Celeste is partly supported by the Research, Evidence and Development Initiative (READ‐It). READ‐It (project number 300342‐104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government's official policies. No known conflicts of interest.

AB: Amanda is partly supported by the Research, Evidence and Development Initiative (READ‐It). READ‐It (project number 300342‐104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government's official policies. No known conflicts of interest.

AS: Anel is partly supported by the Research, Evidence and Development Initiative (READ‐It). READ‐It (project number 300342‐104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government's official policies. No known conflicts of interest.

KN: No known conflicts of interest.

MC: No known conflicts of interest.

JV: No known conflicts of interest.

Figures

1
1
2
2
Risk of bias figure: systematic review authors’ judgements about each risk of bias item presented as percentages across all included trials for bias arising from the randomisation process, and across all outcomes in the Summary of Findings tables for all other items using the Cochrane risk of bias 2 tool
3
3
Funnel plot for change in weight at 3 to < 12 months (Analysis 1.1) in comparison 1
4
4
Funnel plot for change in weight at ≥ 12 months (Analysis 1.9) in comparison 1
5
5
Funnel plot for change in weight at 3 to < 12 months (Analysis 3.1) in comparison 3
1.1
1.1. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 1: Change in body weight (kg) at 3 to < 12 months
1.2
1.2. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 2: Change in body weight (kg) at 3 to < 12 months: subgroup similarity of energy prescription
1.3
1.3. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 3: Change in body weight (kg) at 3 to < 12 months: subgroup extent of carbohydrate restriction
1.4
1.4. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 4: Change in body weight (kg) at 3 to < 12 months: subgroup diagnosed cardiovascular event or disease
1.5
1.5. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 5: Change in body weight (kg) at 3 to < 12 months: subgroup gender
1.6
1.6. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 6: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis overall risk of bias
1.7
1.7. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 7: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis attrition domain
1.8
1.8. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 8: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis source of funding
1.9
1.9. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 9: Change in body weight (kg) at ≥ 12 months
1.10
1.10. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 10: Change in body weight (kg) at ≥ 12 months: sensitivity analysis attrition domain
1.11
1.11. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 11: Change in body weight (kg) at ≥ 12 months: sensitivity analysis source of funding
1.12
1.12. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 12: Number of participants per group with weight loss of at least 5% at 3 to < 12 months
1.13
1.13. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 13: Number of participants per group with weight loss of at least 5% at ≥ 12 months
1.14
1.14. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 14: Change in BMI (kg/m2) at 3 to < 12 months
1.15
1.15. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 15: Change in BMI (kg/m2) at ≥ 12 months
1.16
1.16. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 16: Number of participants per group with reduction in BMI of at least 5% at 3 to < 12 months
1.17
1.17. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 17: Change in DBP (mmHg) at ≥ 12 months
1.18
1.18. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 18: Change in SBP (mmHg) at ≥ 12 months
1.19
1.19. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 19: Change in LDL cholesterol (mmol/L) at ≥ 12 months
1.20
1.20. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 20: Change in HDL cholesterol (mmol/L) at ≥ 12 months
1.21
1.21. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 21: Change in non‐HDL cholesterol (mmol/L) at ≥ 12 months
1.22
1.22. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 22: Change in total cholesterol (mmol/L) at ≥ 12 months
1.23
1.23. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 23: Change in triglycerides (mmol/L) at ≥ 12 months
1.24
1.24. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 24: Constipation at 3 to < 12 months
1.25
1.25. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 25: Constipation at ≥ 12 months
1.26
1.26. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 26: Diarrhoea at 3 to < 12 months
1.27
1.27. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 27: Diarrhoea at ≥ 12 months
1.28
1.28. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 28: Nausea at 3 to < 12 months
1.29
1.29. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 29: Nausea at ≥ 12 months
1.30
1.30. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 30: Flatulence at 3 to < 12 months
1.31
1.31. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 31: Flatulence at ≥ 12 months
1.32
1.32. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 32: Heartburn at 3 to < 12 months
1.33
1.33. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 33: Heartburn at ≥ 12 months
1.34
1.34. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 34: Halitosis at 3 to < 12 months
1.35
1.35. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 35: Stomach upset at 3 to < 12 months
1.36
1.36. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 36: Appetite change at 3 to < 12 months
1.37
1.37. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 37: Appetite change at ≥ 12 months
1.38
1.38. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 38: Fatigue at 3 to < 12 months
1.39
1.39. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 39: Fatigue at ≥ 12 months
1.40
1.40. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 40: Headaches at 3 to < 12 months
1.41
1.41. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 41: Headaches at ≥ 12 months
1.42
1.42. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 42: Reported anxiety at 3 to < 12 months
1.43
1.43. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 43: Total mood disturbances (participant‐reported) at 3 to < 12 months
1.44
1.44. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 44: Total mood disturbances (participant‐reported) at ≥ 12 months
1.45
1.45. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 45: Depressive symptoms (participant‐reported) at 3 to <12 months
1.46
1.46. Analysis
Comparison 1: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase only), Outcome 46: Anxiety symptoms (participant‐reported) at 3 to < 12 months
2.1
2.1. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 1: Change in body weight (kg) at ≥ 12 months
2.2
2.2. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 2: Change in DBP (mmHg) at ≥ 12 months
2.3
2.3. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 3: Change in SBP (mmHg) at ≥ 12 months
2.4
2.4. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 4: Change in LDL cholesterol (mmol/L) at ≥ 12 months
2.5
2.5. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 5: Change in HDL cholesterol (mmol/L) at ≥ 12 months
2.6
2.6. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 6: Change in total cholesterol (mmol/L) at ≥ 12 months
2.7
2.7. Analysis
Comparison 2: Low‐carbohydrate weight‐reducing diets versus balanced carbohydrate weight‐reducing diets in overweight and obese participants without T2DM (weight‐reducing phase followed by weight‐maintenance phase), Outcome 7: Change in triglycerides (mmol/L) at ≥ 12 months
3.1
3.1. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 1: Change in body weight (kg) at 3 to < 12 months
3.2
3.2. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 2: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis overall risk of bias
3.3
3.3. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 3: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis attrition domain
3.4
3.4. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 4: Change in body weight (kg) at 3 to < 12 months: sensitivity analysis source of funding
3.5
3.5. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 5: Change in body weight (kg) at ≥ 12 months
3.6
3.6. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 6: Change in body weight (kg) at ≥ 12 months: sensitivity analysis source of funding
3.7
3.7. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 7: Weight loss of at least 5% at 3 to < 12 months
3.8
3.8. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 8: Weight loss of at least 5% at ≥ 12 months
3.9
3.9. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 9: Change in BMI (kg/m2) at 3 to < 12 months
3.10
3.10. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 10: Change in BMI (kg/m2) at ≥ 12 months
3.11
3.11. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 11: Change in DBP (mmHg) at ≥ 12 months
3.12
3.12. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 12: Change in SBP (mmHg) at ≥ 12 months
3.13
3.13. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 13: Change in HbA1c (%) at ≥ 12 months
3.14
3.14. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 14: Change in LDL cholesterol (mmol/L) at ≥ 12 months
3.15
3.15. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 15: Change in HDL cholesterol (mmol/L) at ≥ 12 months
3.16
3.16. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 16: Change in non‐HDL cholesterol (mmol/L) at ≥ 12 months
3.17
3.17. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 17: Change in total cholesterol (mmol/L) at ≥ 12 months
3.18
3.18. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 18: Change in triglycerides (mmol/L) at ≥ 12 months
3.19
3.19. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 19: Constipation at 3 to < 12 months
3.20
3.20. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 20: Constipation at ≥ 12 months
3.21
3.21. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 21: Diarrhoea 3 to < 12 months
3.22
3.22. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 22: Heartburn symptoms (participant‐reported) at 3 to < 12 months
3.23
3.23. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 23: Appetite change (participant‐reported) at 3 to < 12 months
3.24
3.24. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 24: Headaches at 3 to < 12 months
3.25
3.25. Analysis
Comparison 3: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM (weight‐reducing phase only), Outcome 25: Depressive symptoms (participant‐reported) at 3 to <12 months
4.1
4.1. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 1: Change in body weight (kg) at 3 to < 12 months
4.2
4.2. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 2: Change in body weight (kg) at ≥ 12 months
4.3
4.3. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 3: Change in BMI (kg/m2) at 3 to < 12 months
4.4
4.4. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 4: Change in BMI (kg/m2) at > 12 months
4.5
4.5. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 5: Change in DBP (mmHg) at ≥ 12 months
4.6
4.6. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 6: Change in SBP (mmHg) at ≥ 12 months
4.7
4.7. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 7: Change in HbA1c (%) at ≥ 12 months
4.8
4.8. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 8: Change in LDL cholesterol (mmol/L) at ≥ 12 months
4.9
4.9. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 9: Change in HDL cholesterol (mmol/L) at ≥ 12 months
4.10
4.10. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 10: Change in total cholesterol (mmol/L) at ≥ 12 months
4.11
4.11. Analysis
Comparison 4: Low‐carbohydrate weight‐reducing diets versus balanced‐carbohydrate weight‐reducing diets in overweight and obese participants with T2DM  (weight‐reducing phase followed by weight‐maintenance phase), Outcome 11: Change in triglycerides (mmol/L) at ≥ 12 months
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD013334

References

References to studies included in this review

Aude 2004 {published data only}
    1. Aude Y, Agatston A, Lopez-Jimenez F, Lieberman E, Almon M, Hansen M, et al.The National Cholesterol Education Program Diets a diet lower in carbohydrates and higher in protein and monounsaturated fat. Archives of Internal Medicine 2004;164:2141-6. - PubMed
Bales 2017 {published data only}
    1. Bales C, Porter Starr K, Orenduff M, McDonald S, Molnar K, Jarman A, et al.Influence of protein intake, race and age on responses to a weight-reduction intervention in obese women. Current Developmens in Nutrition 2017;1(5):1-10. [NCT02033655] - PMC - PubMed
Bazzano 2014 {published data only}
    1. Bazzano L, Hu T, Reynolds K, Yao L, Bunol C, Liu Y, et al.Effects of low-carbohydrate and low-fat diets: a randomized trial. Annals of Internal Medicine 2014;161(5):309-18. [NCT00609271] - PMC - PubMed
Benassi‐Evans 2009 {published data only}
    1. Benassi-Evans B, Clifton P, Noakes M, Keogh J, Fenech M.High protein–high red meat versus high carbohydrate weight loss diets do not differ in effect on genome stability and cell death in lymphocytes of overweight men. Mutagenesis 2009;24(3):271-7. [DOI: 10.1093/mutage/gep006] - DOI - PubMed
Brehm 2003 {published data only}
    1. Brehm B, Seeley R, Daniels S, D'Alessio D.A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. Journal of Clinical Endocrinology & Metabolism 2003;88(4):1617-23. [DOI: 10.1210/jc.2002-021480] - DOI - PubMed
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    1. Summer SS, Brehm BJ, Benoit SC, D'Alessio DA.Adiponectin changes in relation to the macronutrient composition of a weight-loss diet. Obesity 2011;19:2198-204. [DOI: 10.1038/oby.2011.60] - DOI - PubMed
Brehm 2005 {published data only}
    1. Brehm B, Spang S, Lattin B, Seeley R, Daniels S, D'Alessio D.The role of energy expenditure in the differential weight loss in obese women on low-fat and low carbohydrate diets. Journal of Clinical Endocrinology and Metabolism 2005;90(3):1475-82. [DOI: 10.1210/jc.2004-1540] - DOI - PubMed
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Calleja‐Fernández 2012 {published data only (unpublished sought but not used)}
    1. Ballesteros-Pomar MD, Calleja-Fernández AR, Vidal-Casariego A, Urioste-Fondo AM, Cano-Rodríguez I.Effectiveness of energy-restricted diets with different protein:carbohydrate ratios: the relationship to insulin sensitivity. Public Health Nutrition 2009;13(12):2119-26. [DOI: 10.1017/S1368980009991881] - DOI - PubMed
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Cornier 2005 {published data only}
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Dyson 2007 {published and unpublished data}
    1. Brand A.Request for additional information: Dyson et al 2010 [personal communication]. Email to: P Dyson 11 June 2020.
    1. Dyson P, Beatty S, Matthews D.A low-carbohydrate diet is more effective in reducing body weight than healthy eating in both diabetic and non-diabetic subjects. Diabetic Medicine 2007;24:1430-5. [DOI: 10.1111/j.1464-5491.2007.02290.x] - DOI - PubMed
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Ebbeling 2007 {published and unpublished data}
    1. Brand A.Request for additional information: Ebbeling et al 2007 [personal communication]. Email to: D. Ludwig 18 February 2020.
    1. Ebbeling C, Leidig M, Feldman H, Lovesky M, Ludwig D.Effects of a low–glycemic load vs low-fat diet in obese young adults: a randomized trial. Journal of the American Medical Association 2007;297(19):2092-102. - PubMed
    1. NCT00130299.An 18-month trial of a low glycemic load diet [An 18-month randomized controlled trial of a low glycemic load diet]. https://clinicaltrials.gov/ct2/show/NCT00130299 (first received 15 August 2005).
Elhayany 2010 {published data only (unpublished sought but not used)}
    1. Elhayany A, Lustman A, Abel R, Attal-Singer J, Vinker S.A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. Diabetes, Obesity and Metabolism 2010;12(3):204-9. [DOI: 10.1111/j.1463-1326.2009.01151.x] - DOI - PubMed
Evangelista 2021 {published data only}
    1. Evangelista LS, Jose MM, Sallam H, Serag H, Golovko G, Khanipov K, et al.High-protein vs. standard-protein diets in overweight and obese patients with heart failure and diabetes mellitus: findings of the Pro-HEART trial. European Society of Cardiology Heart Failure 2021;8(2):1342-8. [DOI: 10.1002/ehf2.13213.] - DOI - PMC - PubMed
    1. Motie M, Evangelista LS, Horwich T, Hamilton M, Lombardo D, Cooper DM, et al.Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics. Contemporary Clinical Trials 2013;36(2):371-81. [DOI: 10.1016/j.cct.2013.08.004] - DOI - PMC - PubMed
    1. NCT01423266.Effects of a high protein diet on clinical outcomes in heart failure [Examining the effects of a high protein diet on adiposity and cardiac structure in patients with heart failure, obesity, and diabetes mellitus]. https://clinicaltrials.gov/ct2/show/NCT01423266 (first received 25 August 2011).
Farnsworth 2003 {published and unpublished data}
    1. A Schoonees.Luscombe et al 2003 [personal communication]. Email to: N. Luscombe-Marsh N 19 January 2017.
    1. Brand A.Request for additional information: Farnsworth et al 2003 [personal communication]. Email to: P. Clifton 4 March 2020.
    1. Brinkworth G, Noakes M, Keogh J, Luscombe N, Wittert G, Clifton P.Long-term effects of a high-protein, low-carbohydrate diet on weight control and cardiovascular risk markers in obese hyperinsulinemic subjects. International Journal of Obesity 2004;28:661-70. [DOI: 10.1038/sj.ijo.0802617] - DOI - PubMed
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Foraker 2014 {published and unpublished data}
    1. Brand A.Request for additional information: Foraker et al 2014 [personal communication]. Email to: M. Pennell 15 July 2020.
    1. Foraker RE, Pennell M, Sprangers P, Vitolins MZ, De Graffinreid C, Paskett ED.Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial. Journal of Women's Health 2014;23(8):675-80. [DOI: 10.1089/jwh.2013.4638] - DOI - PMC - PubMed
    1. Llanos AA, Krok JL, Peng J, Pennell ML, Olivo-Marston S, Vitolins MZ, et al.Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial. Springer Plus 2014;3:175. [DOI: 10.1186/2193-1801-3-175] - DOI - PMC - PubMed
    1. NCT01559194.Low fat versus protein sparing diet for weight loss & impact on biomarkers associated with breast cancer risk (LEAF) [A randomized comparison of a low fat or low carbohydrate dietary pattern for weight loss and impact on biomarkers associated with breast cancer risk in overweight and obese premenopausal women: lifestyle eating and fitness]. https://clinicaltrials.gov/ct2/show/NCT01559194 (first received 21 March 2012).
    1. Olivo-Marston S, Grainger E, Bittoni M, Pennell M, Vitolins MZ, De Graffinreid CR, et al.Biomarkers of breast cancer risk in a randomized trial of a low-fat or low-carbohydrate weight loss intervention and physical activity among overweight and obese premenopausal women. Cancer Research 2012;72(8 Supplement):4456. [DOI: 10.1158/1538-7445.AM2012-4456] - DOI
Foster 2003 {published data only (unpublished sought but not used)}
    1. Foster G, Wyatt HO, Hill J, McGuckin B, Brill C, Mohammed S, et al.A randomized trial of a low-carbohydrate diet for obesity. New English Journal of Medicine 2003;348:2082-90. - PubMed
Foster 2010 {published data only (unpublished sought but not used)}
    1. Foster G, Wyatt H, Hill J, Makris A, Rosenbaum D, Brill C, et al.Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet. Annals of Internal Medicine 2010;153:147-57. [NCT00143936] - PMC - PubMed
    1. Martin CK, Rosenbaum D, Han H, Geiselman P, Wyatt H, Hill J, et al.Change in food cravings, food preferences, and appetite during a low-carbohydrate and low-fat diet. Obesity 2011;19(10):1963-70. [DOI: 10.1038/oby.2011.62] - DOI - PMC - PubMed
Frisch 2009 {published data only}
    1. Frisch S, Zittermann A, Berthold H, Götting C, Kuhn J, Kleesiek K, et al.A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovascular Diabetology 2009;8:36. [DOI: 10.1186/1475-2840-8-36] - DOI - PMC - PubMed
Gardner 2007 {published and unpublished data}
    1. Brand A.Request for additional information: Gardner et al 2007 [personal communication]. Email to: C. Gardner 12 February 2020.
    1. Gardner C, Kiazand A, Alhassan S, Kim S, Stafford R, Balise, R, et al.Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A to Z weight loss study: a randomized trial. Journal of the American Medical Association 2007;297(9):969-77. - PubMed
Goni 2018 {published data only}
    1. Goni L, Riezu-Boj J, Milagro F, Corrales F, Ortiz L, Cuervo M, et al.Interaction between an ADCY3 genetic variant and two weight-lowering diets affecting body fatness and body composition outcomes depending on macronutrient distribution: A randomized trial. Nutrients May 2018;10(789):1-10. [DOI: 10.3390/nu10060789] - DOI - PMC - PubMed
    1. Ramos-Lopez O, Riezu-Boj JI, Milagro FI, Goni L, Cuervo M, Martinez JA.Differential lipid metabolism outcomes associated with ADRB2 gene polymorphisms in response to two dietary interventions in overweight/obese subjects. Nutrition, Metabolism & Cardiovascular Diseases 2018;28:165-72. [DOI: 10.1016/j.numecd.2017.11.006] - DOI - PubMed
    1. Rodriguez-Lozada C, Cuervo M, Cuevas-Sierra A, Goni L, Riezu-Boj JI, Navas-Carretero S, et al.Changes in anxiety and depression traits induced by energy restriction: predictive value of the baseline status. Nutrients 2019;11(6):1206. [DOI: 10.3390/nu11061206] - DOI - PMC - PubMed
Griffin 2013 {published data only}
    1. Cheng H, Griffin H, Claes B, Petocz P, Steinbeck K, Rooney K, et al.Influence of dietary macronutrient composition on eating behaviour and self-perception in young women undergoing weight management. Eating and Weight Disorders 2014;19:241–7. [10.1007/s40519-014-0110-y] - PubMed
    1. Griffin H, Cheng H, O’Connor H, Rooney K, Petocz P, Steinbeck K.Higher protein diet for weight management in young overweight women: a 12-month randomized controlled trial. Diabetes, Obesity and Metabolism 2013;15(6):572-5. [DOI: 10.1111/dom.12056] - DOI - PubMed
Guldbrand 2012 {published data only}
    1. Guldbrand H, Dizdar B, Bunjaku B, Lindström T, Bachrach-Lindström M, Fredrikson M.In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Diabetologia 2012;55:2118-27. [DOI: 10.1007/s00125-012-2567-4] - DOI - PMC - PubMed
    1. Jonasson L, Guldbrand H, Lundberg AK, Nystrom FH.Advice to follow a low-carbohydrate diet has a favourable impact on low-grade inflammation in type 2 diabetes compared with advice to follow a low-fat diet. Annals of Medicine 2014;46(3):182-7. [DOI: 10.3109/07853890.2014.894286] - DOI - PMC - PubMed
Haufe 2013 {published and unpublished data}
    1. Brand A.Request for additional information: Haufe et al 2011 [personal communication]. Email to: S. Haufe 6 August 2019.
    1. Brand A.Request for additional information: Haufe et al 2013 [personal communication]. Email to: S. Haufe 17 February 2020.
    1. Haufe S, Engeli S, Kaminski J, Witt H, Rein D, Kamlage B, et al.Branched-chain amino acid catabolism rather than amino acids plasma concentrations is associated with diet-induced changes in insulin resistance in overweight to obese individuals. Nutrition, Metabolism & Cardiovascular Diseases 2017;27(10):858-64. [DOI: 10.1016/j.numecd.2017.07.001] - DOI - PubMed
    1. Haufe S, Engeli S, Kast P, Böhnke J, Utz W, Haas V, et al.Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects. Hepatology 2011;53:1504-14. [DOI: 10.1002/hep.24242] - DOI - PubMed
    1. Haufe S, Mähler A, Haas V, Luft F, Utz W, Schultz-Menger J, et al.Long-lasting improvements in liver fat and metabolism despite body weight regain after dietary weight loss. Diabetes Care 2013;36:3786-92. [DOI: 10.2337/dc13-0102] [NCT00956566] - DOI - PMC - PubMed
Hockaday 1978 {published data only}
    1. Hockaday T, Hockaday J, Mann J, Turner R.Prospective comparison of modified-fat-high-carbohydrate with standard low-carbohydrate dietary advice in the treatment of diabetes: one year follow-up study. British Journal of Nutrition 1978;39:357-62. - PubMed
Jesudason 2013 {published data only}
    1. Jesudason D, Nordin B, Keogh J, Clifton P.Comparison of 2 weight-loss diets of different protein content on bone health: a randomized trial. American Journal of Clinical Nutrition 2013;98:1343-52. [DOI: 10.3945/ajcn.113.058586] [ACTRN12608000229370.] - DOI - PubMed
Josse 2011 {published and unpublished data}
    1. Brand A.Request for additional information: Josse et al 2011 [personal communication]. Email to: A Josse 4 March 2020.
    1. Josse A, Atkinson S, Tarnopolsky M, Phillip S.Increased consumption of dairy foods and protein during diet- and exercise-induced weight loss promotes fat mass loss and lean mass gain in overweight and obese premenopausal women. Journal of Nutrition 2011;141(9):1626-34. [DOI: 10.3945/jn.111.141028] - DOI - PMC - PubMed
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Juanola‐Falgarona 2014 {published and unpublished data}
    1. Brand A.Request for additional information: Juanola-Falgarona et al 2014 [personal communication]. Email to: M. Bullo 17 April 2020.
    1. Juanola-Falgarona M, Ibarrola-Jurado N, Salas-Salvadó J, Rabassa-Soler A, Bulló M.Design and methods of the GLYNDIET study; assessing the role of glycemic index on weight loss and metabolic risk markers. Nutrición Hospitalaria 2013;28(2):382-90. - PubMed
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Keogh 2007 {published and unpublished data}
    1. Brand A.Request for additional information: Keogh et al 2007 [personal communication]. Email to: J. Keogh 29 April 2020.
    1. Keogh J, Brinkworth G, Clifton P.Effects of weight loss on a low-carbohydrate diet on flow-mediated dilatation, adhesion molecules and adiponectin. British Journal of Nutrition 2007;98:852-9. [DOI: 10.1017/S0007114507747815] - DOI - PubMed
Kitabchi 2013 {published data only}
    1. Kitabchi A, McDaniel K, Wan J, Tylavsky F, Jacovino C, Sands C, et al.Effects of high-protein versus high-carbohydrate diets on markers of b-cell function, oxidative stress, lipid peroxidation, proinflammatory cytokines, and adipokines in obese, premenopausal women without diabetes. Diabetes Care 2013;36:1919-25. [DOI: 10.2337/dc12-1912] [NCT0164284] - DOI - PMC - PubMed
Klemsdal 2010 {published data only}
    1. Klemsdal T, Holme I, Nerland H, Pedersen T, Tonstad S.Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome. Nutrition, Metabolism & Cardiovascular Diseases 2010;20:195-201. [DOI: 10.1016/j.numecd.2009.03.010] - DOI - PubMed
Krebs 2012 {published data only}
    1. Krebs J, Elley C, Parry-Strong A, Lunt H, Drury P, Bell D, et al.The Diabetes Excess Weight Loss (DEWL) trial: a randomised controlled trial of high-protein versus high-carbohydrate diets over 2 years in type 2 diabetes. Diabetologia 2012;55:905-14. [DOI: 10.1007/s00125-012-2461-0] - DOI - PubMed
Landers 2002 {published data only}
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Larsen 2011 {published and unpublished data}
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Lasker 2008 {published data only}
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Layman 2005 {published data only}
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Layman 2009 {published data only (unpublished sought but not used)}
    1. Evans E, Mojtahedi M, Thorpe M, Valentine R, Kris-Etherton P, Layman D.Effects of protein intake and gender on body composition changes: a randomized clinical weight loss trial. Nutrition and Metabolism 2012;9:55. [DOI: 10.1186/1743-7075-9-55] - DOI - PMC - PubMed
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Lean 1997 {published data only}
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Lim 2010 {published and unpublished data}
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Liu 2013 {published data only (unpublished sought but not used)}
    1. Liu X, Zhang G, Ye X, Li H, Chen X, Tang L, et al.Effects of a low-carbohydrate diet on weight loss and cardiometabolic profile in Chinese women: a randomised controlled feeding trial. British Journal of Nutrition 2013;110:1444-53. [DOI: 10.1017/S0007114513000640] - DOI - PubMed
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Marco‐Benedi 2019 {published and unpublished data}
    1. Brand A.Request for additional information: Marco-Benedi et al 2019 [personal communication]. Email to: R. Mateo-Gallego 8 April 2020.
    1. Marco-Benedí V, Perez-Calahorra S, Bea A, Lamiquiz-Moneo I, Baila-Rueda L, Cenarro A, et al.High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity. Clinical Nutrition 2020;39(5):1354-63. [DOI: 10.1016/j.clnu.2019.06.005] - DOI - PubMed
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Mateo‐Gallego 2017 {published and unpublished data}
    1. Brand A.Request for additional information: Mateo-Gallego et al 2017 [personal communication]. Email to: R. Mateo-Gallego 3 March 2020.
    1. Mateo-Gallego R, Lamiquiz-Moneo I, Perez-Calahorra S, Marco-Benedí V, Bea A, Baila-Rueda L, et al.Different protein composition of low-calorie diet differently impacts adipokine profile irrespective of weight loss in overweight and obese women. Nutrition, Metabolism and Cardiovascular Diseases 2018;28:133-42. [DOI: 10.1016/j.numecd.2017.10.024] - DOI - PubMed
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Mellberg 2014 {published data only (unpublished sought but not used)}
    1. Mellberg C, Sandberg S, Ryberg M, Eriksson M, Brage S, Larsson C, et al.Long-term effects of a Palaeolithic-type diet in obese postmenopausal women: a two-year randomized trial. European Journal of Clinical Nutrition 2014;68(3):350-7. [DOI: 10.1038/ejcn.2013.290.] - DOI - PMC - PubMed
Ooi 2021 {published data only}
    1. Ooi DS, Ling JQ, Sadananthan SA, Velan SS, Ong FY, Khoo CM, et al.Branched-chain amino acid supplementation does not preserve lean mass or affect metabolic profile in adults with overweight or obesity in a randomized controlled weight loss intervention. Journal of Nutrition 2021;151(4):911-20. [DOI: 10.1093/jn/nxaa414.] - DOI - PubMed
Parr 2016 {published data only}
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Pedersen 2014 {published and unpublished data}
    1. Brand A.Request for additional information: Pedersen, Jesudason & Clifton 2014 [personal communication]. Email to: P. Clifton 26 February 2020.
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Pittas 2005 {published data only (unpublished sought but not used)}
    1. Pittas A, Das S, Hajduk C, Golden J, Saltzman E, Stark P, et al.A low–glycemic load diet facilitates greater weight loss in overweight adults with high insulin secretion but not in overweight adults with low insulin secretion in the CALERIE trial. Diabetes Care 2005;28(12):2939-41. - PubMed
Racette 1995 {published data only (unpublished sought but not used)}
    1. Racette S, Schoeller D, Kushner R, Neil K, Herling-laffalda K.Effects of aerobic exercise and dietary carbohydrate on energy expenditure and body composition during weight reduction in obese women. American Journal of Clinical Nutrition 1995;61:486-94. - PubMed
Ruth 2013 {published data only (unpublished sought but not used)}
    1. Ruth M, Port A, Shah M, Bourland A, Istfan N, Nelson K, et al.Consuming a hypocaloric high fat low carbohydrate diet for 12 weeks lowers C-reactive protein, and raises serum adiponectin and high density lipoprotein-cholesterol in obese subjects. Metabolism 2013;62(12):1-17. [DOI: 10.1016/j.metabol.2013.07.006.] - DOI - PMC - PubMed
Sacks 2009 {published and unpublished data}
    1. Brand A.Request for additional information: Sacks et al 2009 [personal communication]. Email to: F. Sacks 28 July 2020.
    1. De Jonge L, Bray GA, Smith SR, Ryan DH, De Souza R, Loria CM, et al.Effect of diet composition and weight loss on resting energy expenditure in the POUNDS LOST study. Obesity 2012;20(12):2384-9. [DOI: 10.1038/oby.2012.127] - DOI - PMC - PubMed
    1. Naude C.Data [personal communication]. Email to: F. Sacks 9 November 2012.
    1. Sacks F, Bray G, Carey V, Smith S, Ryan D, Anton S, et al.Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. New English Journal of Medicine 2009;360(9):859-73. [NCT00072995] - PMC - PubMed
    1. Williamson DA, Anton SD, Han H, Champagne CM, Allen R, Leblanc E, et al.Early behavioral adherence predicts short and long-term weight loss in the POUNDS LOST study. Journal of Behavioral Medicine 2010;33(4):305-14. [DOI: 10.1007/s10865-010-9253-0] - DOI - PMC - PubMed
Samaha 2003 {published data only}
    1. Samaha F, Iqbal N, Seshadri P, Chicano K, Daily D, McGrory J, et al.A low-carbohydrate as compared with a low-fat diet in severe obesity. New English Journal of Medicine 2003;348(21):2074-81. - PubMed
    1. Seshadri P, Samaha FF, Stern L, Ahima RS, Daily D, Iqbal N.Adipocytokine changes caused by low-carbohydrate compared to conventional diets in obesity. Metabolic Syndrome and Related Disorders 2005;3(1):66-74. [DOI: 10.1089/met.2005.3.66] - DOI - PubMed
    1. Stern L, Iqbal N, Seshadri P, Chicano KL, Daily DA, McGrory J, et al.The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Annals of Internal Medicine 2004;140(10):778-85. [DOI: 10.7326/0003-4819-140-10-200405180-00007] - DOI - PubMed
Saslow 2017a {published data only (unpublished sought but not used)}
    1. Saslow L, Daubenmier J, Moskowitz J, Kim S, Murphy E, Phinney S, et al.Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutrition and Diabetes 2017;7(304):1-7. [DOI: 10.1038/s41387-017-0006-9] - DOI - PMC - PubMed
    1. Saslow L, Kim S, Daubenmier J, Moskowitz J, Phinney S, Goldman V, et al.A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLOS One 2014;9(4):e91027. - PMC - PubMed
Sato 2017 {published and unpublished data}
    1. Brand A.Request for additional information: Sato et al 2017 [personal communication]. Email to: J. Sato 29 May 2020.
    1. Sato J, Kanazawa A, Hatae C, Makita S, Komiya K, Shimizu T, et al.One year follow-up after a randomized controlled trial of a 130 g/day low-carbohydrate diet in patients with type 2 diabetes mellitus and poor glycemic control. PLOS ONE 2017;12(12):e0188892. [DOI: 10.1371/ journal.pone.0188892] - PMC - PubMed
    1. Sato J, Kanazawa A, Makita S, Hatae C, Komiya K, Shimizu T, et al.A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control. Clinical Nutrition 2017;36:992-1000. [DOI: 10.1016/j.clnu.2016.07.003] - DOI - PubMed
Stentz 2016 {published data only (unpublished sought but not used)}
    1. NCT01642849.Effect of diet composition on weight change and metabolic parameters. https://clinicaltrials.gov/ct2/show/NCT01642849 (first posted 17 July 2012).
    1. Stentz F, Brewer A, Wan J, Garber C, Daniels B, Sands C, et al.Remission of pre-diabetes to normal glucose tolerance in obese adults with high protein versus high carbohydrate diet: randomized control trial. British Medical Journal 2016;4:1-9. [DOI: 10.1136/bmjdrc-2016- 000258] - PMC - PubMed
Tay 2008 {published data only (unpublished sought but not used)}
    1. Brinkworth GD, Buckley JD, Noakes M, Clifton PM, Wilson CJ.Long-term effects of a very low-carbohydrate diet and a low-fat diet on mood and cognitive function. Archives of Internal Medicine 2009;169(20):1873-80. [DOI: 10.1001/archinternmed.2009.329] - DOI - PubMed
    1. Brinkworth GD, Noakes M, Buckley JD, Keogh JB, Clifton PM.Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo. American Journal of Clinical Nutrition 2009;90:23-32. - PubMed
    1. Moran LJ, Wilson CJ, Buckley JD, Noakes M, Clifton PM, Brinkworth GD.Changes in endothelial function and depression scores are associated following long-term dietary intervention: a secondary analysis. Nutrition 2013;29(10):1271-4. [DOI: 10.1016/j.nut.2013.03.023] - DOI - PubMed
    1. Tay J, Brinkworth G, Noakes M, Keogh J, Clifton P.Metabolic effects of weight loss on a very-low-carbohydrate diet compared with an isocaloric high-carbohydrate diet in abdominally obese subjects. Journal of the American College of Cardiology 2008;51(1):59-67. [DOI: 10.1016/j.jacc.2007.08.050] - DOI - PubMed
    1. Wycherley T, Brinkworth G, Keogh J, Noakes M, Buckley J, Clifton P.Long-term effects of weight loss with a very low carbohydrate and low fat diet on vascular function in overweight and obese patients. Journal of Internal Medicine 2010;267(5):452-61. - PubMed
Tay 2014 {published data only}
    1. Brinkworth GD, Luscombe-Marsh ND, Thompson CH, Noakes M, Buckley JD, Wittert G, et al.Long-term effects of very low-carbohydrate and high-carbohydrate weight-loss diets on psychological health in obese adults with type 2 diabetes: randomized controlled trial. Journal of Internal Medicine 2016;280(4):388-97. [DOI: 10.1111/joim.12501] - DOI - PubMed
    1. Tay J, Luscombe-Marsh N, Thompson C, Noakes M, Buckley J, Wittert G, et al.A very low-carbohydrate, low–saturated fat diet for type 2 diabetes management: a randomized trial. Diabetes Care 2014;37:2909-18. [DOI: 10.2337/dc14-0845/-/DC1] [ACTRN12612000369820] - DOI - PubMed
    1. Tay J, Luscombe-Marsh ND, Thompson CH, Noakes M, Buckley JD, Wittert GA, et al.Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial. American Journal of Clinical Nutrition 2015;102(4):780-90. [DOI: 10.3945/ajcn.115.112581] - DOI - PubMed
    1. Tay J, Thompson CH, Luscombe-Marsh ND, Noakes M, Buckley JD, Wittert GA, et al.Long-term effects of a very low carbohydrate compared with a high carbohydrate diet on renal function in individuals with type 2 diabetes. Medicine 2015;94(47):e2181. [DOI: 10.1097/MD.0000000000002181] - DOI - PMC - PubMed
    1. Tay J, Thompson CH, Luscombe-Marsh ND, Wycherley TP, Noakes M, Buckley JD, et al.Effects of an energy-restricted low-carbohydrate, high unsaturated fat/low saturated fat diet versus a high-carbohydrate, low-fat diet in type 2 diabetes: a 2-year randomized clinical trial. Diabetes, Obesity and Metabolism 2018;20(4):858-71. [DOI: 10.1111/dom.13164] - DOI - PubMed
Veum 2017 {published data only}
    1. Veum V, Laupsa-Borge J, Eng Ø, Rostrup E, Larsen T, Nordrehaug J, et al.Visceral adiposity and metabolic syndrome after very high-fat and low-fat isocaloric diets: a randomized controlled trial. American Journal of Clinical Nutrition 2017;105:85-99. [DOI: 10.3945/ajcn.115.123463] [NCT01750021] - DOI - PubMed
Volek 2009 {published data only}
    1. Volek J, Phinney S, Forsythe C, Quann E, Wood R, Puglisi M, et al.Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids 2009;44:297-309. [DOI: 10.1007/s11745-008-3274-2] - DOI - PubMed
Watson 2016 {published data only}
    1. Watson N, Dyer K, Buckley J, Brinkworth G, Coates A, Parfitt G, et al.Effects of low-fat diets differing in protein and carbohydrate content on cardiometabolic risk factors during weight loss and weight maintenance in obese adults with type 2 diabetes. Nutrients 2016;8(289):1-15. [DOI: 10.3390/nu8050289] - DOI - PMC - PubMed
    1. Watson NA, Dyer KA, Buckley JD, Brinkworth GD, Coates AM, Parfitt G, et al.Comparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: a randomised clinical trial. Nutrition Journal 2018;17(62):1-12. - PMC - PubMed
    1. Watson NA, Dyer KA, Buckley JD, Brinkworth GD, Coates AM, Parfitt G, et al.Reductions in food cravings are similar with low-fat weight loss diets differing in protein and carbohydrate in overweight and obese adults with type 2 diabetes: a randomized clinical trial. Nutrition Research 2018;57:56-66. - PubMed
Westman 2008 {published data only}
    1. NCT00415688.Lifestyle modification for obesity-related type 2 diabetes. https://clinicaltrials.gov/ct2/show/NCT00415688 (first received 25 December 2006).
    1. Westman E, Yancy W, Mavropoulos J, Marquart M, McDuffie J.The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus. Nutrition and Metabolism 2008;5:36. [DOI: 10.1186/1743-7075-5-36] - DOI - PMC - PubMed
Wycherley 2010 {published data only}
    1. ACTRN12608000206325.2008 weight loss diets and resistance exercise training in type 2 diabetes study [A randomised study to evaluate high protein diets and resistance exercise training in type 2 diabetes study 2008]. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82626 (first received 11 April 2008).
    1. Wycherley T, Noakes M, Clifton P, Cleanthous X, Keogh J, Brinkworth G.A high-protein diet with resistance exercise training improves weight loss and body composition in overweight and obese patients with type 2 diabetes. Diabetes Care 2010;33(5):969-76. - PMC - PubMed
Wycherley 2012 {published and unpublished data}
    1. ACTRN12606000002583.Diet and weight loss in men [The effect of a high protein low carbohydrate compared to a high carbohydrate diet moderate protein diet on weight loss and wellbeing in obese men]. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=516 (first received 12 September 2005).
    1. Brand A.ACTR No: 126000002583 related to Wycherley et al 2013 [personal communication]. Email to: Australian NZ Clinical Trials Registry 11 August 2020.
    1. Brand A.Request for additional information: Wycherley et al 2012 and Wycherley et al 2013 [personal communication]. Email to: T. Wycherley 26 August 2020.
    1. Lutze J, Taylor P, Brinkworth GD, Wyld B, Syrette J, Wilson CJ, et al.Psychological well-being response to high protein and high carbohydrate weight loss diets in overweight and obese men: a randomised trial. e-SPEN Journal 2013;8(6):e232-40. [DOI: 10.1016/j.clnme.2013.08.002] - DOI
    1. Moran LJ, Brinkworth GD, Martin S, Wycherley TP, Stuckey B, Lutze J, et al.Long-term effects of a randomised controlled trial comparing high protein or high carbohydrate weight loss diets on testosterone, SHBG, erectile and urinary function in overweight and obese men. PLOS ONE 2016;11(9):e0161297. - PMC - PubMed
Yamada 2014 {published data only}
    1. Yamada Y, Uchida J, Izumi H, Tsukamoto Y, Inoue G, Watanabe Y, et al.A non-calorie-restricted low-carbohydrate diet is effective as an alternative therapy for patients with type 2 diabetes. Internal Medicine 2014;53:13-9. [DOI: 10.2169/internalmedicine.53.0861] - DOI - PubMed

References to studies excluded from this review

Ben Avraham 2009 {published data only}
    1. Ben-Avraham S, Harman-Boehm I, Schwarzfuchs D, Shai I.Dietary strategies for patients with type 2 diabetes in the era of multi-approaches; review and results from the Dietary Intervention Randomized Controlled Trial (DIRECT). Diabetes Research and Clinical Practice 2009;86(Suppl 1):S41-8. [DOI: 10.1016/s0168-8227(09)70008-7] - DOI - PubMed
Bluher 2010 {published data only}
    1. Blüher M, Rudich A, Klöting N, Golan R, Rubin E, Schwarzfuchs D, et al.Two major patterns of dynamics in adipokine serum concentrations over 2 years of dietary weight-loss intervention. Diabetologia 2010;53(Suppl 1):S367. [DOI: 10.1007/s00125-010-1872-z] - DOI
Bluher 2012 {published data only}
    1. Blüher M, Rudich A, Klöting N, Golan R, Henkin Y, Rubin E, et al.Two patterns of adipokine and other biomarker dynamics in a long-term weight loss intervention. Diabetes Care 2012;35(2):342-9. [DOI: 10.2337/dc11-1267] - DOI - PMC - PubMed
Brehm 2009 {published data only}
    1. Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, et al.One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care 2009;32(2):215-20. [DOI: 10.2337/dc08-0687] - DOI - PMC - PubMed
Brun 2011 {published and unpublished data}
    1. Brun J-F, Fédou C, Raynaud De Mauverger E.More sustained weight loss after a diet moderately enriched in purified protein compared to low fat diet in obese subjects. Clinical Nutrition Supplements 2011;6(1):103. [DOI: 10.1016/S1744-1161(11)70263-0] - DOI
Campbell 2012 {published and unpublished data}
    1. Campbell DD, Meckling KA.Effect of the protein: carbohydrate ratio in hypoenergetic diets on metabolic syndrome risk factors in exercising overweight and obese women. British Journal of Nutrition 2012;108(9):1658-71. [DOI: 10.1017/s0007114511007215] - DOI - PubMed
Daly 2006 {published data only}
    1. Daly ME, Paisey R, Millward BA, Eccles C, Williams K, Hammersley S, et al.Short-term effects of severe dietary carbohydrate-restriction advice in type 2 diabetes - a randomized controlled trial. Diabetic Medicine 2006;23(1):15-20. [DOI: 10.1111/j.1464-5491.2005.01760.x] - DOI - PubMed
Davis 2009 {published and unpublished data}
    1. Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, et al.Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care 2009;32(7):1147-52. [DOI: 10.2337/dc08-2108] - DOI - PMC - PubMed
Davis 2012 {published and unpublished data}
    1. Davis NJ, Tomuta N, Isasi CR, Leung V, Wylie-Rosett J.Diabetes-specific quality of life after a low-carbohydrate and low-fat dietary intervention. Diabetes Educator 2012;38(2):250-5. [DOI: 10.1177/0145721711436132] - DOI - PubMed
Djuric 2002 {published data only}
    1. Djuric Z, Lababidi S, Heilbrun LK, Depper JB, Poore KM, Uhley VE.Effect of low-fat and/or low-energy diets on anthropometric measures in participants of the women's diet study. Journal of the American College of Nutrition 2002;21(1):38-46. [DOI: 10.1080/07315724.2002.10719192.] - DOI - PubMed
Dorling 2020 {published data only}
    1. Dorling JL, Das SK, Racette SB, Apolzan JW, Zhang D, Pieper CF, et al.Changes in body weight, adherence, and appetite during 2 years of calorie restriction: the CALERIE 2 randomized clinical trial. European Journal of Clinical Nutrition 2020;74(8):1210-20. [DOI: 10.1038/s41430-020-0593-8.] - DOI - PMC - PubMed
Fabricatore 2011 {published data only}
    1. Fabricatore AN, Wadden TA, Ebbeling CB, Thomas JG, Stallings VA, Schwartz S, et al.Targeting dietary fat or glycemic load in the treatment of obesity and type 2 diabetes: a randomized controlled trial. Diabetes Research and Clinical Practice 2011;92(1):37-45. [DOI: 10.1016/j.diabres.2010.12.016.] - DOI - PMC - PubMed
Gardner 2018 {published and unpublished data}
    1. Gardner CD, Trepanowski JF, Del Gobbo LC, Hauser ME, Rigdon J, Ioannidis JP, et al.Effect of low-fat vs low-carbohydrate diet on 12-month weight loss in overweight adults and the association with genotype pattern or insulin secretion: the DIETFITS randomized clinical trial. JAMA 2018;319(7):667-79. [DOI: 10.1001/jama.2018.0245.] - DOI - PMC - PubMed
Golan 2012 {published data only}
    1. Golan R, Tirosh A, Schwarzfuchs D, Harman-Boehm I, Thiery J, Fiedler GM, et al.Dietary intervention induces flow of changes within biomarkers of lipids, inflammation, liver enzymes, and glycemic control. Nutrition 2012;28(2):131-7. [DOI: 10.1016/j.nut.2011.04.001] - DOI - PMC - PubMed
Greenberg 2009 {published data only}
    1. Greenberg I, Stampfer MJ, Schwarzfuchs D, Shai I, DIRECT Group.Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT). Journal of the American College of Nutrition 2009;28(2):159-68. [DOI: 10.1080/07315724.2009.10719767.] - DOI - PubMed
Guo 2019 {published and unpublished data}
    1. Guo J, Robinson JL, Gardner CD, Hall KD.Objective versus self-reported energy intake changes during low-carbohydrate and low-fat diets. Obesity 2019;27(3):420-6. [DOI: 10.1002/oby.22389] - DOI - PMC - PubMed
Iqbal 2010 {published data only}
    1. Iqbal N, Vetter ML, Moore RH, Chittams JL, Dalton-Bakes CV, Dowd M, et al.Effects of a low-intensity intervention that prescribed a low-carbohydrate vs. a low-fat diet in obese, diabetic participants. Obesity 2010;18(9):1733-8. [DOI: 10.1038/oby.2009.460] - DOI - PubMed
Itsiopoulos 2011 {published data only}
    1. Itsiopoulos C, Brazionis L, Kaimakamis M, Cameron M, Best JD, O'Dea K, et al.Can the Mediterranean diet lower HbA1c in type 2 diabetes? Results from a randomized cross-over study. Nutrition, Metabolism & Cardiovascular Diseases 2011;21(9):740-7. [DOI: 10.1016/j.numecd.2010.03.005] - DOI - PubMed
Jönsson 2009 {published and unpublished data}
    1. Jönsson T, Granfeldt Y, Ahrén B, Branell U-C, Pålsson G, Hansson A, et al.Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovascular Diabetology 2009;8(35):1-14. [DOI: 10.1186/1475-2840-8-35] - DOI - PMC - PubMed
Leichtle 2011 {published data only}
    1. Leichtle AB, Helmschrodt C, Ceglarek U, Shai I, Henkin Y, Schwarzfuchs D, et al.Effects of a 2-y dietary weight-loss intervention on cholesterol metabolism in moderately obese men. American Journal of Clinical Nutrition 2011;94(5):1189‐95. [DOI: 10.3945/ajcn.111.018119] - DOI - PubMed
Lindeberg 2007 {published and unpublished data}
    1. Lindeberg S, Jönsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjöström K, et al.A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia 2007;50(9):1795-807. [DOI: 10.1007/s00125-007-0716-y] - DOI - PubMed
Locke 2020 {published data only}
    1. Locke SR, Falkenhain K, Lowe DA, Lee T, Singer J, Weiss EJ, et al.Comparing the Keyto app and device with Weight Watchers' WW app for weight loss: protocol for a randomized trial. JMIR Research Protocols 2020;9(8):e19053. [DOI: 10.2196/19053] - DOI - PMC - PubMed
Luger 2013 {published data only}
    1. Luger M, Holstein B, Schindler K, Kruschitz R, Ludvik B.Feasibility and efficacy of an isocaloric high-protein vs. standard diet on insulin requirement, body weight and metabolic parameters in patients with type 2 diabetes on insulin therapy. Experimental and Clinical Endocrinology & Diabetes 2013;121(5):286-94. [DOI: 10.1055/s-0033-1341472] - DOI - PubMed
Ma 2008 {published data only}
    1. Ma Y, Olendzki BC, Merriam PA, Chiriboga DE, Culver AL, Li W, et al.A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Nutrition 2008;24(1):45-56. [DOI: 10.1016/j.nut.2007.10.008] - DOI - PMC - PubMed
McIver 2010 {published and unpublished data}
    1. McIver CM, Clifton PM.High protein weight loss and gene expression in overweight/obese women. Obesity Reviews 2010;11(Suppl 1):97.
McIver 2011 {published and unpublished data}
    1. McIver CM, Clifton PM.High-protein, weight loss down-regulates gene expression involved in fatty acid and mitochondrial energy metabolism. Australasian Medical Journal 2011;4(12):732 .
McLaughlin 2016 {published and unpublished data}
    1. McLaughlin T, Liu L-F, Avery E, Shen W-J, Cohen C, Kraemer F, et al.Effect of low carbohydrate weight loss diet on adipose cell size. Diabetes 2016;65(Suppl 1):A443-4. [DOI: 10.2337/db16-1695-1770] - DOI
Melanson 2012 {published data only}
    1. Melanson KJ, Summers A, Nguyen V, Brosnahan J, Lowndes J, Angelopoulos TJ, et al.Body composition, dietary composition, and components of metabolic syndrome in overweight and obese adults after a 12-week trial on dietary treatments focused on portion control, energy density, or glycemic index. Nutrition Journal 2012;11(57):1-9. [DOI: 10.1186/1475-2891-11-57] - DOI - PMC - PubMed
Millward 2014 {published and unpublished data}
    1. Millward DJ, Truby H, Fox KR, Livingstone MB, Macdonald IA, Tothill P.Sex differences in the composition of weight gain and loss in overweight and obese adults. British Journal of Nutrition 2014;111(5):933-43. [DOI: 10.1017/S0007114513003103] - DOI - PubMed
Morgan 2009 {published and unpublished data}
    1. Morgan LM, Griffin BA, Millward DJ, DeLooy A, Fox KR, Baic S, et al.Comparison of the effects of four commercially available weight-loss programmes on lipid-based cardiovascular risk factors. Public Health Nutrition 2009;12(6):799‐807. [DOI: 10.1017/S1368980008003236] - DOI - PubMed
NCT00200720 {published data only}
    1. NCT00200720.Effectiveness of a low carbohydrate diet versus a high carbohydrate diet in promoting weight loss and improved health. https://clinicaltrials.gov/ct2/show/NCT00200720 (first received 20 September 2005).
NCT00990457 {published data only}
    1. NCT00990457.Evaluating the effects two diets combined with exercise in persons with abdominal obesity (the SHAPE5 study). https://clinicaltrials.gov/ct2/show/NCT00990457 (first received 6 October 2009).
Nielsen 2005 {published data only}
    1. Nielsen JV, Jönsson E, Nilsson A-K.Lasting improvement of hyperglycaemia and bodyweight: low-carbonhydrate diet in type 2 diabetes. A brief report. Upsala Journal of Medical Sciences 2005;110(1):69-74. [DOI: ] - PubMed
Reid 2009 {published data only}
    1. Reid J, Mukhtar R, Fishlock H, Taylor G, Reckless J.The effect of three dietary interventions on PAI-1 among metabolic syndrome subjects. Atherosclerosis Supplements 2009;10(2):e1459. [DOI: 10.1016/S1567-5688(09)71417-5] - DOI
Sakae 2015 {published data only}
    1. Sakae PN, Bianco HT, Camargo LM, Carvalho JG, Izar MC, Ihara SS, et al.Effect of high protein/very low carbohydrate diet and standard hypocaloric diet in obese subjects: nutritional, biochemical and endothelial function evaluations. Biochimica et Biophysica Acta Clinical 2015;3(Suppl):S7. [DOI: 10.1016/j.bbacli.2015.05.020] - DOI
Saslow 2017b {published data only}
    1. Saslow L, Mason E, Kim S, Goldman V, Ploutz-Snyder R, Bayandorian H, et al.An online intervention comparing a very low-carbohydrate ketogenic diet and lifestyle recommendations versus a plate method diet in overweight individuals with type 2 diabetes: a randomized controlled trial. Journal of Medical Internet Research 2017;19(2):e36. [DOI: 10.2196/jmir.5806.] - DOI - PMC - PubMed
Shai 2008 {published data only}
    1. Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, et al.Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. New England Journal of Medicine 2008;359(3):229‐41. [DOI: 10.1056/NEJMoa0708681] - DOI - PubMed
Shai 2010 {published data only}
    1. Shai I, Spence JD, Schwarzfuchs D, Henkin Y, Parraga G, Rudich A, et al.Dietary intervention to reverse carotid atherosclerosis. Circulation 2010;121(10):1200-8. [DOI: 10.1161/circulationaha.109.879254] - DOI - PubMed
Shih 2019 {published and unpublished data}
    1. Shih CW, Hauser ME, Aronica L, Rigdon J, Gardner CD.Changes in blood lipid concentrations associated with changes in intake of dietary saturated fat in the context of a healthy low-carbohydrate weight-loss diet: a secondary analysis of the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial. American Journal of Clinical Nutrition 2019;109(2):433-41. [DOI: 10.1093/ajcn/nqy305] - DOI - PMC - PubMed
Stewart 2013 {published data only}
    1. Stewart KJ, Dobrosielski DA, Silber HA, Shapiro EP, Wang N-Y, Ouyang P.Six months of a low-carbohydrate versus low-fat weight loss diet plus exercise: effects on resting and postprandial endothelial function. Circulation 2013;128(Suppl 22):A18552. [DOI: 10.1161/circ.128.suppl_22.A18552] - DOI
Toobert 2003 {published data only}
    1. Toobert DJ, Glasgow RE, Strycker LA, Barrera M Jnr, Radcliffe JL, Wander RC, et al.Biologic and quality-of-life outcomes from the Mediterranean Lifestyle Program: a randomized clinical trial. Diabetes Care 2003;26(8):2288-93. [DOI: 10.2337/diacare.26.8.2288] - DOI - PubMed
Trepanowski 2017 {published and unpublished data}
    1. Trepanowski JF, Gardner CD.Improved insulin sensitivity with a healthy low fat or a healthy low carbohydrate weight loss diet: a twelve month randomized trial. Circulation 2017;135(Suppl 1):AP226. [DOI: 10.1161/circ.135.suppl_1.p226] - DOI
Vetter 2010 {published data only}
    1. Vetter ML, Wade A, Womble LG, Dalton-Bakes C, Wadden TA, Iqbal N.Effect of a low-carbohydrate diet versus a low-fat, calorie-restricted diet on adipokine levels in obese, diabetic participants. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2010;3:357-61. [DOI: 10.2147/dmsott.s13966] - DOI - PMC - PubMed
Wood 2012 {published data only}
    1. Wood RJ, Gregory SM, Sawyer J, Milch CM, Matthews TD, Headley SA.Preservation of fat-free mass after two distinct weight loss diets with and without progressive resistance exercise. Metabolic Syndrome and Related Disorders 2012;10(3):167-74. [DOI: 10.1089/met.2011.0104] - DOI - PubMed
Wycherley 2013 {published data only}
    1. Wycherley TP, Buckley JD, Noakes M, Clifton PM, Brinkworth GD.Comparison of the effects of weight loss from a high-protein versus standard-protein energy-restricted diet on strength and aerobic capacity in overweight and obese men. European Journal of Nutrition 2013;52(1):317-25. [DOI: 10.1007/s00394-012-0338-0] - DOI - PubMed
Yancy 2015 {published and unpublished data}
    1. Yancy WS Jnr, Mayer SB, Coffman CJ, Smith VA, Kolotkin RL, Geiselman PJ, et al.Effect of allowing choice of diet on weight loss: a randomized trial. Annals of Internal Medicine 2015;162(12):805-14. [DOI: 10.7326/m14-2358] - DOI - PMC - PubMed
Zelicha 2018 {published data only}
    1. Zelicha H, Schwarzfuchs D, Shelef I, Gepner Y, Tsaban G, Tene L, et al.Changes of renal sinus fat and renal parenchymal fat during an 18-month randomized weight loss trial. Clinical Nutrition 2018;37(4):1145-53. [DOI: 10.1016/j.clnu.2017.04.007] - DOI - PubMed

References to studies awaiting assessment

Aller 2019 {published data only}
    1. Aller R, Izaola O, Primo D, De Luis DA.The effect of single-nucleotide polymorphisms at the ADIPOQ gene locus rs1501299 on metabolic parameters after 9 mo of a high-protein/low-carbohydrate versus a standard hypocaloric diet. Nutrition 2019;65:44-9. [DOI: ] - PubMed
Cui 2006 {published data only}
    1. Cui MH, Tomuta V, Jayatillake H, Segal-Isaacson CJ, Hwang JH, Stein DT.Impact of low carbohydrate vs low fat weight loss diets on intramyocellular lipids and insulin sensitivity in obese subjects: a randomized cross over trial. Diabetes 2006;55:A332-3.
De Luis 2007 {published data only}
    1. De Luis DA, Aller R, Izaola O, Gonzalez Sagrado M, Bellioo D, Conde R.Effects of a low-fat versus a low-carbohydrate diet on adipocytokines in obese adults. Hormone Research 2007;67(6):296-300. [DOI: ] - PubMed
De Luis 2009a {published data only}
    1. De Luis DA, Aller R, Izaola O, Sagrado MG, Conde R.The effects of a low-fat versus a low carbohydrate diet in obese adults [Efectos de una dieta baja en grasas frente a una dieta rica en proteinas y grasa en pacientes obesos]. Medicina Clínica 2009;132(6):203-7. [DOI: DOI: 10.1016/j.medcli.2008.03.003] - PubMed
De Luis 2009b {published data only}
    1. De Luis DA, Sagrado MG, Conde R, Aller R, Izaola O.The effects of two different hypocaloric diets on glucagon-like peptide 1 in obese adults, relation with insulin response after weight loss. Journal of Diabetes and Its Complications 2009;23(4):239-43. [DOI: 10.1016/j.jdiacomp.2007.12.006] - DOI - PubMed
De Luis 2010a {published data only}
    1. De Luis DA, Aller R, Izaola O, Gonzalez Sagrado M, Conde R.Effect of two different hypocaloric diets in transaminases and insulin resistance in nonalcoholic fatty liver disease and obese patients. Nutrición Hospitalaria 2010;25(5):730-5. [DOI: 10.3305/nh.2010.25.5.4643] - DOI - PubMed
De Luis 2010b {published data only}
    1. De Luis DA, Sagrado MG, Aller R, Izaola O, Conde R.Effects of C358A missense polymorphism of the degrading enzyme fatty acid amide hydrolase on weight loss, adipocytokines, and insulin resistance after 2 hypocaloric diets. Metabolism: Clinical and Experimental 2010;59(9):1387-92. [DOI: 10.1016/j.metabol.2009.12.029] - DOI - PubMed
De Luis 2012 {published data only}
    1. De Luis DA, Sagrado MG, Aller R, Conde R, Izaola O, De la Fuente B, et al.Role of G1359A polymorphism of the cannabinoid receptor gene on weight loss and adipocytokines levels after two different hypocaloric diets. Journal of Nutritional Biochemistry 2012;23(3):287-91. [DOI: 10.1016/j.jnutbio.2010.12.006] - DOI - PubMed
De Luis 2015 {published data only}
    1. De Luis DA, Aller R, Izaola O, De la Fuente B, Romero E.Genetic variation in the beta-3-adrenoreceptor gene (Trp64arg polymorphism) and their influence on anthropometric parameters and insulin resistance after a high protein/low carbohydrate versus a standard hypocaloric diet [Variación genética en el gen beta-3-adrenorreceptor (Trp64arg polimorfismo) y su influencia en parámetros antropométricos y resistencia a la insulina después de una dieta con alto contenido en proteínas/baja en carbohidratos versus una dieta estándar hipocalórica]. Nutrición Hospitalaria 2015;32(2):487-93. [DOI: 10.3305/nh.2015.32.2.9293.] - DOI - PubMed
De Luis 2015a {published data only}
    1. De Luis DA, Aller R, Izaola O, Primo D, Urdiales S, Romero E.Effects of a high-protein/low-carbohydrate diet versus a standard hypocaloric diet on weight and cardiovascular risk factors: role of a genetic variation in the rs9939609 FTO gene variant. Journal of Nutrigenetics and Nutrigenomics 2015;8(3):128-36. [DOI: 10.1159/000441142] - DOI - PubMed
De Luis 2015b {published data only}
    1. De Luis DA, Aller R, Izaola O, Romero E.Effects of a high-protein/low-carbohydrate versus a standard hypocaloric diet on adipocytokine levels and cardiovascular risk factors during 9 months, role of rs6923761 gene variant of glucagon-like peptide 1 receptor. Journal of Endocrinological Investigation 2015;38(11):1183-9. [DOI: 10.1007/s40618-015-0304-9] - DOI - PubMed
De Luis 2015c {published data only}
    1. De Luis DA, Aller R, Izaola O, Díaz Soto G, López Gómez JJ, Gómez Hoyos E, et al.Effects of a high-protein/low-carbohydrate versus a standard hypocaloric diet on weight and cardiovascular risk factors during 9 months: role of a genetic variation in the cannabinoid receptor gene (CNR1) (G1359A polymorphism). Annals of Nutrition and Metabolism 2015;66(2-3):125-31. [DOI: 10.1159/000375412] - DOI - PubMed
De Luis 2015d {published data only}
    1. De Luis DA, Izaola O, Aller R, De la Fuente B, Bachiller R, Romero E.Effects of a high-protein/low carbohydrate versus a standard hypocaloric diet on adipocytokine levels and insulin resistance in obese patients along 9 months. Journal of Diabetes and Its Complications 2015;29(7):950-4. [DOI: 10.1016/j.jdiacomp.2015.06.002] - DOI - PubMed
De Luis 2015e {published data only}
    1. De Luis DA, Izaola O, De la Fuente B, Primo D, Romero E.Role of fatty acid-binding protein 2 Ala54Thr genotype on weight loss and cardiovascular risk factors after a high-protein/low-carbohydrate versus a standard hypocaloric diet during 9 months. Annals of Nutrition and Metabolism 2015;67(2):81-6. [DOI: 10.1159/000438947] - DOI - PubMed
De Luis 2016 {published data only}
    1. De Luis DA, Aller R, Izaola O, Romero E.Association of the TNF-alpha-308 G/A polymorphisms with metabolic responses secondary to a high protein/low carbohydrate versus a standard hypocaloric diet [Asociación del polimorfismo TNF-alpha -308 G/A con los cambios metabólicos secundarios a una dieta hipocalórica rica en proteínas/baja en hidratos de carbono versus una dieta hipocalórica estándar]. Nutrición Hospitalaria 2016;33(3):602-8. [DOI: 10.20960/nh.267] - DOI - PubMed
De Luis 2016a {published data only}
    1. De Luis DA, Aller R, Izaola O, Romero E.Effect of -55CT polymorphism of UCP3 on insulin resistance and cardiovascular risk factors after a high protein/low carbohydrate versus a standard hypocaloric diet. Annals of Nutrition and Metabolism 2016;68(3):157-63. [DOI: 10.1159/000444150] - DOI - PubMed
De Luis 2016b {published data only}
    1. De Luis D, Aller R, Izaola O, Romero E.Role of-55CT polymorphism of UCP3 on insulin resistance factors after 9 months of high protein/low carbohydrate vs. a standard hypocaloric diet. Diabetes 2016;65(Suppl 1):A560. [DOI: ] - PubMed
De Luis 2017 {published data only}
    1. De Luis DA, Izaola O, Primo D, Aller R.Polymorphism rs16147 of the neuropeptide Y gene modifies the response of cardiovascular risk biomarkers and adipokines to two hypocaloric diets. Journal of Nutrigenetics and Nutrigenomics 2017;10(1-2):63-72. [DOI: 10.1159/000478528] - DOI - PubMed
De Luis 2018 {published data only}
    1. De Luis DA, Mulero I, Primo D, Izaola O, Aller R.Effects of polymorphism rs3123554 in the cannabinoid receptor gene type 2 (CB2R) on metabolic and adiposity parameters after weight loss with two hypocaloric diets. Diabetes Research and Clinical Practice 2018;139:339-47. [DOI: 10.1016/j.diabres.2018.02.030] - DOI - PubMed
De Luis 2018a {published data only}
    1. De Luis DA, Izaola O, Primo D, Aller R.Impact of 2 different hypocaloric diets on serum omentin levels in obese subjects. Annals of Nutrition and Metabolism 2018;73(2):138-44. [DOI: 10.1159/000489130] - DOI - PubMed
De Luis 2019 {published data only}
    1. De Luis DA, Izaola O, Primo D, Aller R.Different effects of high-protein/low-carbohydrate versus standard hypocaloric diet on insulin resistance and lipid profile: role of rs16147 variant of neuropeptide Y. Diabetes Research and Clinical Practice 2019 Aug 23 [Epub];156:107825. [DOI: 10.1016/j.diabres.2019.107825] - DOI - PubMed
De Luis 2019a {published data only}
    1. De Luis D, Izaola O, Primo D, Aller R.Role of rs670 variant of APOA1 gene on metabolic response after a high fat vs. a low fat hypocaloric diets in obese human subjects. Journal of Diabetes and Its Complications 2019;33(3):249-54. [DOI: 10.1016/j.jdiacomp.2018.10.015] - DOI - PubMed
De Luis 2020 {published data only}
    1. De Luis DA, Izaola O, Primo D, Aller R.A circadian rhythm-related MTNR1B genetic variant (rs10830963) modulate body weight change and insulin resistance after 9 months of a high protein/low carbohydrate vs a standard hypocaloric diet. Journal of Diabetes and Its Complications 2020 Jan 13 [Epub];34(4):107534. [DOI: 10.1016/j.jdiacomp.2020.107534] - DOI - PubMed
De Luis 2020a {published data only}
    1. De Luis DA, Primo D, Izaola O, Aller R.Adiponectin gene variant rs266729 interacts with different macronutrient distribution of two different hypocaloric diets. Lifestyle Genomics 2020;13(1):20-7. [DOI: 10.1159/000503863] - DOI - PubMed
De Luis 2021 {published data only}
    1. De Luis D, Primo MD, Izaola O.Adiponectin gene variant rs266729 interacts with different macronutrient distributions of two different hypocaloric diets during nine months [La variante del gen de la adiponectina rs266729 interactúa con diferentes distribuciones de macronutrientes de dos dietas hipocalóricas durante nueve meses]. Nutrición Hospitalaria 2021;38(2):274-80. [DOI: 10.20960/nh.03423.] - DOI - PubMed
Evangelista 2009 {published data only}
    1. Evangelista LS, Heber D, Li Z, Bowerman S, Hamilton MA, Fonarow GC.Reduced body weight and adiposity with a high-protein diet improves functional status, lipid profiles, glycemic control, and quality of life in patients with heart failure: a feasibility study. Journal of Cardiovascular Nursing 2009;24(3):207-15. [DOI: 10.1097/JCN.0b013e31819846b9] - DOI - PMC - PubMed
Evangelista 2017 {published data only}
    1. Evangelista LS, Lombardo D, Horwich T, Hamilton M, Fonarow GC.High vs. standard protein diets in obese patients with heart failure: effects on chronic disease risks. Circulation 2017;135(Suppl 1):AP167. [DOI: 10.1161/circ.135.suppl_1.p167] - DOI
Fernandez 2020 {published data only}
    1. Fernandez C, Bazzano L.The effects of ideal protein versus low-fat/low-calorie weight loss diets: the RENEWAL trial. Obesity 2020;28(Suppl 2):167.
Fleming 2002 {published data only}
    1. Fleming RM.The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors. Preventive Cardiology 2002;5(3):110-8. [DOI: 10.1111/j.1520-037x.2002.01231.x.] - DOI - PubMed
Greene 2004 {published data only}
    1. Greene PJ, Devecis J, Willett WC.Effects of low-fat vs ultra-low-carbohydrate weight-loss diets: a 12-week pilot feeding study. Journal of Parenteral and Enteral Nutrition 2004;28(Suppl 1):S13-4. [DOI: 10.1177/01486071040280S101] - DOI
Izaola 2019 {published data only}
    1. Izaola O, Primo D, Gomez Hoyos E, Lopez Gomez JJ, Ortola A, De Luis D.Association of rs670 variant of APOA1 gene with lipid profile and insulin resistance after 9 months of a high protein/low carbohydrate vs a standard hypocaloric diet. Clinical Nutrition 2020;39(4):988-93. [DOI: 10.1016/j.clnu.2019.04.030] - DOI - PubMed
Mukhtar 2009 {published data only}
    1. Mukhtar RY, Reid J, Fishlock HF, Taylor GJ, Reckless JP.The effect of three dietary regimens on insulin resistance in metabolic syndrome subjects. Diabetes 2009;58(Suppl 1):A.
Sun 2019 {published data only (unpublished sought but not used)}
    1. Sun J, Xu N, Lin N, Wu P, Yuan K, An S, et al.Optimal weight loss effect of short-term low carbohydrate diet with calorie restriction on overweight/obese subjects in South China - a multicenter randomized controlled trial. Diabetes 2019;68(Suppl 1):317-LB. [DOI: ]

References to ongoing studies

NCT03832933 {published data only}
    1. NCT03832933.Comparing high and normal protein diets for the dietary remission of type 2 diabetes. http://clinicaltrials.gov/ct2/show/NCT03832933 (first received 6 February 2019).
NCT04014296 {published data only}
    1. NCT04014296.Weight loss in adults over 50 with obesity. https://clinicaltrials.gov/ct2/show/NCT04014296 (first received 10 July 2019).
NCT04023942 {published data only}
    1. NCT04023942.Personalized nutrition and e-health: lifestyle intervention study for weight loss maintenance (LION). https://clinicaltrials.gov/ct2/show/NCT04023942 (first received 18 July 2019).
NCT04136093 {published data only}
    1. NCT04136093.Diet for the maintenance of weight loss and metabolic health in obese postmenopausal women (WELCOME). https://clinicaltrials.gov/ct2/show/NCT04136093 (first received 23 October 2019).
NCT04192357 {published data only}
    1. NCT04192357.A randomised controlled trial of a weight loss maintenance program for adults with obesity. https://clinicaltrials.gov/ct2/show/NCT04192357 (first received 10 December 2019).
NCT04230928 {published data only}
    1. NCT04230928.Giving a low carbohydrate diet to overcome hypertension (GLOH). https://clinicaltrials.gov/ct2/show/NCT04230928 (first received 18 January 2020).
NCT04382183 {published data only}
    1. NCT04382183.Impact of ketogenic diets in preventing relapse in obesity management (Ketomaintain). https://clinicaltrials.gov/ct2/show/NCT04382183 (first received 11 May 2020).
NCT04699448 {published data only}
    1. NCT04699448.Gene-diet interactions on body weight regulation and lifestyle parameters (iMPROVE) [Genetic predisposition and body weight regulation. Evaluation of target-genes in overweight and obese adults, under different dietary interventions]. https://clinicaltrials.gov/ct2/show/NCT04699448 (first received 7 January 2021).
NCT04745572 {published data only}
    1. NCT04745572.Development of an adaptive treatment for weight loss in people with prediabetes [Development of an adaptive treatment strategy for weight loss in people with prediabetes using a sequential multiple assignment randomized trial]. https://clinicaltrials.gov/ct2/show/NCT04745572 (first received 9 February 2021).

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References to other published versions of this review

Naude 2019
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