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Randomized Controlled Trial
. 2025 Mar 8;24(1):88.
doi: 10.1186/s12944-025-02500-1.

Reduction of cardiovascular risk factors by the diet - Evaluation of the MoKaRi concept by a parallel-designed randomized study

Christine Dawczynski  1   2 , Timo Drobner  3   4 , Thomas Weidauer  3   4 , Peter Schlattmann  5 , Michael Kiehntopf  6 , Daniela Weber  7   8   9 , Tilman Grune  7   8 , Winfried März  9   10 , Marcus E Kleber  11 , Stefan Lorkowski  4   12
Affiliations
Randomized Controlled Trial

Reduction of cardiovascular risk factors by the diet - Evaluation of the MoKaRi concept by a parallel-designed randomized study

Christine Dawczynski et al. Lipids Health Dis. .

Abstract

Background and aim: The MoKaRi study aims to evaluate the impact of two nutritional concepts on cardiometabolic risk factors.

Methods: For our 20-week intervention study, 65 participants with moderate elevated low-density lipoprotein cholesterol (LDL-C; ≥ 3 mmol/l) and without lipid-lowering therapy were recruited. The intervention to improve nutritional behavior was based on individualized menu plans which were characterized by defined energy and nutrient intake. To improve compliance, individual nutritional counselling sessions were held every two weeks. In addition to motivation, cooking skills were strengthened and nutritional knowledge was imparted. Follow-up visits were carried out after 10 and 20 weeks.

Results: The MoKaRi diet lowered the concentrations of total cholesterol (menu plan group (MP): -15%; menu plan plus fish oil group (MP-FO): -11%), LDL-C (MP: -14%; MP-FO: -16%) and non-high-density lipoprotein cholesterol (MP: -16%; MP-FO: -13%) (p < 0.001). Body weight (MP: -5%; MP-FO: -8%; p < 0.05), waist circumference (MP: -6%; MP-FO: -9%) as well as diastolic blood pressure (MP: -8%; MP-FO: -8%), apolipoprotein A1 (MP: -15%; MP-FO: -20%), apolipoprotein B (MP: -15%; MP-FO: -6%) and glycated hemoglobin A1c (HbA1c) (MP: -1.8%; MP-FO: -3.6%) were also reduced in both groups after 20 weeks (p < 0.05). In both intervention groups, a maximum reduction in LDL-c of approx. 26% was achieved within the 20 weeks of intervention. Individual participants achieved a reduction of 45-49%. The supplementation of fish oil on top of the menu plans resulted in more substantial effects on body weight (MP: -5% vs. MP-FO: -8%), body fat (MP: -11% vs. MP-FO: -20%), triglycerides (MP: -14% vs. MP-FO: -28%), high-sensitivity C-reactive protein (MP: -19% vs. MP-FO: -43%) and HbA1c (MP: -1.8% vs. MP-FO:-3.6%; p < 0.05).

Conclusions: The MoKaRi diet resulted in a significant reduction of cardiometabolic risk factors. Our data highlights the additional benefit of the combination between menu plans and fish oil supplementation, which resulted in more substantial effects on body weight, BMI, TG, HbA1c and hs-CRP.

Gov identifier: NCT02637778.

Keywords: Cardiovascular risk; Dietary fibers; Fatty acids; Nutritional concepts.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: All participants were informed about the aims and scope of the study by the study leader, and if they agreed, they provided written informed consent. All study procedures were carried out in accordance with the Declaration of Helsinki (1989) of the World Medical Association. The study protocol has been approved by the responsible ethical committee (Ethical Committee of the Friedrich-Schiller-University, file number 4656-01/16). The MoKaRi study was registered before launching (ClinicalTrials.gov Identifier: NCT02637778; https://clinicaltrials.gov/ct2/show/NCT02637778 ). Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart diagram of the MoKaRi study. 85 subjects were screened for eligibility. 20 subjects had to be excluded, so that 65 subjects were randomized into the two intervention groups. After completion of the study, 26 and 25 participants were included in the statistical analyses
Fig. 2
Fig. 2
Design of the MoKaRi study. Abbreviations: DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; LDL-C, low-density lipoprotein cholesterol; MP, menu plan; MP-FO, menu plan plus fish oil
Fig. 3
Fig. 3
Change of (A) EPA, (B) DPA and (C) DHA in erythrocyte lipids (EL) over the study course in the MP group (Figure 3 A1-C1) and the MP-FO group (Figure 3 A2-C2). Abbreviations: DHA, docosahexaenoic acid; DPA, docosapentaenoic acid; EPA, eicosapentaenoic acid; EL, erythrocyte lipids; FAME, fatty acid methyl ester
Fig. 4
Fig. 4
Concentrations at baseline (week 0) and after 20 weeks (change from baseline cfb) for each individual participant in the MP group (left) and the MP-FO group (right)—A1-2: Total cholesterol (TC, mmol/l), B1-2: LDL-C and min LDL-C (mmol/l), C1-2: sdLDL-C (mmol/l), D1-2: apolipoprotein B (mg/l), E1-2: TG (mmol/l)
Fig. 5
Fig. 5
Body weight (kg) over the course of the MoKaRi study (13 times) in both study groups. Data at baseline (week 0), after weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 as well as follow-up (week 30 and 40) are shown as median (25th, 75th percentile) according to the statistical test that was performed; times without a common letter are significantly different, p < 0.05; Abbreviations: MP, menu plan; MP-FO, menu plan plus fish oil
Fig. 6
Fig. 6
LDL-C (mmol/l) over the course of the MoKaRi study (13 times) in both study groups. Data at baseline (week 0), after weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 as well as follow-up (week 30 and 40) are shown as median (25th, 75th percentile) according to the statistical test that was performed; times without a common letter are significantly different, p < 0.05; Abbreviations: LDL-C, low-density lipoprotein cholesterol; MP, menu plan; MP-FO, menu plan plus fish oil
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