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Meta-Analysis
. 2019 Mar 13;3(3):CD009825.
doi: 10.1002/14651858.CD009825.pub3.

Mediterranean-style diet for the primary and secondary prevention of cardiovascular disease

Karen Rees  1 , Andrea Takeda, Nicole Martin, Leila Ellis, Dilini Wijesekara, Abhinav Vepa, Archik Das, Louise Hartley, Saverio Stranges
Affiliations
Meta-Analysis

Mediterranean-style diet for the primary and secondary prevention of cardiovascular disease

Karen Rees et al. Cochrane Database Syst Rev. .

Abstract

Background: The Seven Countries study in the 1960s showed that populations in the Mediterranean region experienced lower coronary heart disease (CHD) mortality probably as a result of different dietary patterns. Later observational studies have confirmed the benefits of adherence to a Mediterranean dietary pattern on cardiovascular disease (CVD) risk factors but clinical trial evidence is more limited.

Objectives: To determine the effectiveness of a Mediterranean-style diet for the primary and secondary prevention of CVD.

Search methods: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9); MEDLINE (Ovid, 1946 to 25 September 2018); Embase (Ovid, 1980 to 2018 week 39); Web of Science Core Collection (Thomson Reuters, 1900 to 26 September 2018); DARE Issue 2 of 4, 2015 (Cochrane Library); HTA Issue 4 of 4, 2016 (Cochrane Library); NHS EED Issue 2 of 4, 2015 (Cochrane Library). We searched trial registers and applied no language restrictions.

Selection criteria: We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). Both of the following key components were required to reach our definition of a Mediterranean-style diet: high monounsaturated/saturated fat ratio (use of olive oil as main cooking ingredient and/or consumption of other traditional foods high in monounsaturated fats such as tree nuts) and a high intake of plant-based foods, including fruits, vegetables and legumes. Additional components included: low to moderate red wine consumption; high consumption of whole grains and cereals; low consumption of meat and meat products and increased consumption of fish; moderate consumption of milk and dairy products. The intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, usual care or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow-up periods of three months or more defined as the intervention period plus post intervention follow-up.

Data collection and analysis: Two review authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted four main comparisons:1. Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention;2. Mediterranean dietary intervention versus another dietary intervention for primary prevention;3. Mediterranean dietary intervention versus usual care for secondary prevention;4. Mediterranean dietary intervention versus another dietary intervention for secondary prevention.

Main results: In this substantive review update, 30 RCTs (49 papers) (12,461 participants randomised) and seven ongoing trials met our inclusion criteria. The majority of trials contributed to primary prevention: comparisons 1 (nine trials) and 2 (13 trials). Secondary prevention trials were included for comparison 3 (two trials) and comparison 4 (four trials plus an additional two trials that were excluded from the main analyses due to published concerns regarding the reliability of the data).Two trials reported on adverse events where these were absent or minor (low- to moderate-quality evidence). No trials reported on costs or health-related quality of life.Primary preventionThe included studies for comparison 1 did not report on clinical endpoints (CVD mortality, total mortality or non-fatal endpoints such as myocardial infarction or stroke). The PREDIMED trial (included in comparison 2) was retracted and re-analysed following concerns regarding randomisation at two of 11 sites. Low-quality evidence shows little or no effect of the PREDIMED (7747 randomised) intervention (advice to follow a Mediterranean diet plus supplemental extra-virgin olive oil or tree nuts) compared to a low-fat diet on CVD mortality (hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.50 to 1.32) or total mortality (HR 1.0, 95% CI 0.81 to 1.24) over 4.8 years. There was, however, a reduction in the number of strokes with the PREDIMED intervention (HR 0.60, 95% CI 0.45 to 0.80), a decrease from 24/1000 to 14/1000 (95% CI 11 to 19), moderate-quality evidence). For CVD risk factors for comparison 1 there was low-quality evidence for a possible small reduction in total cholesterol (-0.16 mmol/L, 95% CI -0.32 to 0.00) and moderate-quality evidence for a reduction in systolic (-2.99 mmHg (95% CI -3.45 to -2.53) and diastolic blood pressure (-2.0 mmHg, 95% CI -2.29 to -1.71), with low or very low-quality evidence of little or no effect on LDL or HDL cholesterol or triglycerides. For comparison 2 there was moderate-quality evidence of a possible small reduction in LDL cholesterol (-0.15 mmol/L, 95% CI -0.27 to -0.02) and triglycerides (-0.09 mmol/L, 95% CI -0.16 to -0.01) with moderate or low-quality evidence of little or no effect on total or HDL cholesterol or blood pressure.Secondary preventionFor secondary prevention, the Lyon Diet Heart Study (comparison 3) examined the effect of advice to follow a Mediterranean diet and supplemental canola margarine compared to usual care in 605 CHD patients over 46 months and there was low-quality evidence of a reduction in adjusted estimates for CVD mortality (HR 0.35, 95% CI 0.15 to 0.82) and total mortality (HR 0.44, 95% CI 0.21 to 0.92) with the intervention. Only one small trial (101 participants) provided unadjusted estimates for composite clinical endpoints for comparison 4 (very low-quality evidence of uncertain effect). For comparison 3 there was low-quality evidence of little or no effect of a Mediterranean-style diet on lipid levels and very low-quality evidence for blood pressure. Similarly, for comparison 4 where only two trials contributed to the analyses there was low or very low-quality evidence of little or no effect of the intervention on lipid levels or blood pressure.

Authors' conclusions: Despite the relatively large number of studies included in this review, there is still some uncertainty regarding the effects of a Mediterranean-style diet on clinical endpoints and CVD risk factors for both primary and secondary prevention. The quality of evidence for the modest benefits on CVD risk factors in primary prevention is low or moderate, with a small number of studies reporting minimal harms. There is a paucity of evidence for secondary prevention. The ongoing studies may provide more certainty in the future.

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Conflict of interest statement

KR: none known.

AT: none known.

NM: none known.

LE: none known.

DW: none known.

AV: none known.

AD: none known.

LH: none known.

SS: none known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 1 Total cholesterol (mmol/L), change from baseline.
1.2
1.2. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 2 LDL cholesterol (mmol/L), change from baseline.
1.3
1.3. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 3 HDL cholesterol (mmol/L), change from baseline.
1.4
1.4. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 4 Triglycerides (mmol/L), change from baseline.
1.5
1.5. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 5 Systolic blood pressure (mmHg), change from baseline.
1.6
1.6. Analysis
Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention, Outcome 6 Diastolic blood pressure (mmHg), change from baseline.
2.1
2.1. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 1 Composite clinical events (CVD death, stroke, MI).
2.2
2.2. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 2 CVD mortality.
2.3
2.3. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 3 Total mortality.
2.4
2.4. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 4 Myocardial infarction.
2.5
2.5. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 5 Stroke.
2.6
2.6. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 6 Peripheral arterial disease.
2.7
2.7. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 7 Incidence type 2 diabetes.
2.8
2.8. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 8 Stroke (unadjusted).
2.9
2.9. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 9 Total cholesterol (mmol/L), change from baseline.
2.10
2.10. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 10 LDL cholesterol (mmol/L), change from baseline.
2.11
2.11. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 11 HDL cholesterol (mmol/L), change from baseline.
2.12
2.12. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 12 Triglycerides (mmol/L), change from baseline.
2.13
2.13. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 13 Systolic blood pressure (mmHg), change from baseline.
2.14
2.14. Analysis
Comparison 2 Mediterranean dietary intervention versus another dietary intervention for primary prevention, Outcome 14 Diastolic blood pressure (mmHg), change from baseline.
3.1
3.1. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 1 Total mortality.
3.2
3.2. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 2 CVD mortality.
3.3
3.3. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 3 CVD death plus non‐fatal MI.
3.4
3.4. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 4 Total cholesterol (mmol/L), change from baseline.
3.5
3.5. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 5 LDL cholesterol (mmol/L), change from baseline.
3.6
3.6. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 6 HDL cholesterol (mmol/L), change from baseline.
3.7
3.7. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 7 Triglycerides (mmol/L), change from baseline.
3.8
3.8. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 8 Systolic blood pressure (mmHg), change from baseline.
3.9
3.9. Analysis
Comparison 3 Mediterranean dietary intervention versus usual care for secondary prevention, Outcome 9 Diastolic blood pressure (mmHg), change from baseline.
4.1
4.1. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 1 Non‐fatal MI.
4.3
4.3. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 3 Fatal MI.
4.5
4.5. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 5 Sudden cardiac death.
4.7
4.7. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 7 Total cardiac endpoints (fatal and non‐fatal MI, sudden cardiac death).
4.9
4.9. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 9 Total mortality.
4.11
4.11. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 11 CVD mortality.
4.13
4.13. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 13 Total cardiac endpoints (all‐cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina or stroke, unadjusted).
4.14
4.14. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 14 Total cholesterol (mmol/L), change from baseline.
4.16
4.16. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 16 LDL cholesterol (mmol/L), change from baseline.
4.17
4.17. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 17 LDL cholesterol (mmol/L), change from baseline (sensitivity analysis without Singh studies).
4.18
4.18. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 18 HDL cholesterol (mmol/L), change from baseline.
4.19
4.19. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 19 HDL cholesterol (mmol/L), change from baseline (sensitivity analysis without Singh studies).
4.20
4.20. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 20 Triglycerides (mmol/L), change from baseline.
4.21
4.21. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 21 Triglycerides (mmol/L), change from baseline (sensitivity analysis without Singh studies).
4.22
4.22. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 22 Systolic blood pressure (mmHg), change from baseline.
4.23
4.23. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 23 Systolic blood pressure (mmHg), change from baseline (sensitivity analysis without Singh studies).
4.24
4.24. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 24 Diastolic blood pressure (mmHg), change from baseline.
4.25
4.25. Analysis
Comparison 4 Mediterranean dietary intervention versus another dietary intervention for secondary prevention, Outcome 25 Diastolic blood pressure (mmHg), change from baseline (sensitivity analysis without Singh studies).
See this image and copyright information in PMC

Update of

Comment in

References

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Properzi 2018 {published data only}
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Tuttle 2008 {published data only}
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Wardle 2000 {published data only}
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References to studies excluded from this review

Abedi 2010 {published data only}
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Burr 2003 {published data only}
    1. Burr ML, Ashfield‐Watt PAL, Dunstan FDJ, Fehily AM, Breay P, Ashton T, et al. Lack of benefit of dietary advice to men with angina: results of a controlled trial. European Journal of Clinical Nutrition 2003;57:193–200. - PubMed
Conlin 2000 {published data only}
    1. Conlin PR, Chow D, Miller IER, Svetkey LP, Lin PH, Harsha DW, et al. The effect of dietary patterns on blood pressure control in hypertensive patients: results from the Dietary Approaches to Stop Hypertension (DASH) trial. American Journal of Hypertension 2000;13(9):949‐55. - PubMed
CRESSIDA {published data only}
    1. Reidlinger DP, Darzi J, Hall WL, Maniou Z, Govoni V, Seed P, et al. The effectiveness of an integrated dietary intervention compared with an average UK diet in reducing cardiovascular disease risk factors in older men and women aged 40 to 70 years: the CRESSIDA study. Proceedings of the Nutrition Society. 2013; Vol. 72:E249.
    1. Reidlinger DP, Darzi J, Hall WL, Seed PT, Chowienczyk PJ, Sanders TAB. How effective are current dietary guidelines for cardiovascular disease prevention in healthy middle‐aged and older men and women? A randomized controlled trial. American Journal of Clinical Nutrition 2015;101(5):922‐30. - PubMed
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de la Iglesia 2013 {published data only}
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ENCORE {published data only}
    1. Blumenthal JA, Babyak MA, Hinderliter A, Watkins LL, Craighead L, Lin PH, et al. Effects of the DASH diet alone and in combination with exercise and weight loss on blood pressure and cardiovascular biomarkers in men and women with high blood pressure: the ENCORE study. Archives of Internal Medicine 2010;170(2):126‐35. - PMC - PubMed
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Jula 2002 {published data only}
    1. Jula A, Marniemi J, Huupponen R, Virtanen A, Rastas M, Ronnemaa T, et al. Effects of diet and simvastatin on serum lipids, insulin, and antioxidants in hypercholesterolemic men: a randomized controlled trial. JAMA 2002;287(5):598‐605. - PubMed
Lankinen 2014 {published data only}
    1. Lankinen M, Kolehmainen M, Jaaskelainen T, Paananen J, Joukamo L, Kangas AJ, et al. Effects of whole grain, fish and bilberries on serum metabolic profile and lipid transfer protein activities: a randomized trial (Sysdimet). PloS One 2014;9(2):e90352. [DOI: 10.1371/journal.pone.0090352] - DOI - PMC - PubMed
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Lima 2013 {published data only}
    1. Lima ST, Silva Nalin de Souza B, Franca AK, Salgado Filho N, Sichieri R. Dietary approach to hypertension based on low glycaemic index and principles of DASH (Dietary Approaches to Stop Hypertension): a randomised trial in a primary care service. British Journal of Nutrition 2013;110(8):1472‐9. - PubMed
Lindeberg 2007 {published data only}
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Mayneris‐Perxachs 2014 {published data only}
    1. Mayneris‐Perxachs J, Sala‐Vila A, Chisaguano M, Castellote A, Estruch R, Covas M, et al. Effects of 1‐year intervention with a Mediterranean diet on plasma fatty acid composition and metabolic syndrome in a population at high cardiovascular risk. PloS One 2014;9(3):e85202. [DOI: 10.1371/journal.pone.0085202] - DOI - PMC - PubMed
Mezzano 2003 {published data only}
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Wade 2017 {published data only}
    1. ACTRN12616000309482. The effect of a Mediterranean Diet, with adequate dairy foods, to meet Australian recommendations, on cardiometabolic and cognitive health outcomes in men and women at high risk of cardiovascular disease. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=1261... (first received 17 December 2015).
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WHI {published data only}
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References to ongoing studies

Delgado‐Lista 2016 {published data only}
    1. Delgado‐Lista J, Perez‐Martinez P, Garcia‐Rios A, Alcala‐Diaz JF, Perez‐Caballero AI, Gomez‐Delgado F, et al. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low‐fat diet on cardiovascular disease in coronary patients [NCT00924937]. American Heart Journal 2016;177:42‐50. - PMC - PubMed
    1. NCT00924937. Coronary diet intervention with olive oil and cardiovascular prevention (CORDIOPREV). clinicaltrials.gov/ct2/show/NCT00924937 (first received 19 June 2009).
Hardman 2015 {published data only}
    1. Hardman RJ, Kennedy G, Macpherson H, Scholey AB, Pipingas A. A randomised controlled trial investigating the effects of Mediterranean diet and aerobic exercise on cognition in cognitively healthy older people living independently within aged care facilities: the Lifestyle Intervention in Independent Living Aged Care (LIILAC) study protocol [ACTRN12614001133628]. Nutrition Journal 2015;14:53. - PMC - PubMed
Itsiopoulos 2018 {published data only}
    1. ACTRN12616000156482. The AUSMED Heart Trial: the Australian Mediterranean diet trial for secondary prevention of heart disease [The effects of a Mediterranean dietary intervention in modifying cardiovascular risk factors in high‐risk individuals who have experienced a cardiac event]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369896 (first received 12 January 2016).
    1. Itsiopoulos C. The Australian Mediterranean diet heart trial (AUSMED Heart Trial): a randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: study protocol. American Heart Journal 2018;203:4‐11. - PubMed
NCT03053843 {published data only}
    1. NCT03053843. Mediterranean diet plus extravirgin olive oil in the prevention of recurrent arrhythmias [PREvención Con DIeta Mediterránea de Arritmias Recurrentes Trial (PREDIMAR)]. clinicaltrials.gov/ct2/show/nct03053843 (first received 15 February 2017).
NCT03129048 {published data only}
    1. NCT03129048. Mediterranean diet, weight loss, and cognition in obese older adults. clinicaltrials.gov/ct2/show/nct03129048 (first received 26 April 2017).
Papamiltiadous 2016 {published data only}
    1. Papamiltiadous ES, Roberts SK, Nicoll AJ, Ryan MC, Itsiopoulos C, Salim A, et al. A randomised controlled trial of a Mediterranean dietary intervention for adults with non alcoholic fatty liver disease (MEDINA): study protocol [ACTRN12615001010583]. BMC Gastroenterology 2016;16:14. [DOI: 10.1186/s12876-016-0426-3] - DOI - PMC - PubMed
Sotos‐Prieto 2017 {published data only}
    1. Sotos‐Prieto M, Cash SB, Christophi C, Folta S, Moffatt S, Muegge C, et al. Rationale and design of feeding America's bravest: Mediterranean diet‐based intervention to change firefighters' eating habits and improve cardiovascular risk profiles. Contemporary Clinical Trials 2017;61:101‐7. - PubMed

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