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

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 A(1c) (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.