A study protocol of a randomized trial evaluating the effect of using defined menu plans within an intensive personal nutritional counseling program on cardiovascular risk factors: The MoKaRi (modulation of cardiovascular risk factors) trial

IMPORTANCE: Changes in dietary habits and lifestyle can reduce the risk of cardiovascular disease which is the leading cause of death worldwide. Objectives of the MoKaRi study The MoKaRi (modulation of cardiovascular risk factors) intervention study is designed to evaluate the effectiveness and potential of the developed MoKaRi concept. The MoKaRi concept comprises three components, each designed to improve dietary behavior. The first component entails using daily menu plans to implement a defined “cardioprotective diet”. This diet consists of seasonal menu plans which are characterized by: (i) a personalized energy supply depending on his or her age, gender, level of physical activity. (ii) an adequate intake of carbohydrates, protein, fat, vitamins, minerals, and trace elements according to the guidelines of the German Society of Nutrition (DGE). (iii) a recommended intake of saturated fatty acids (SFA; < 7% of caloric intake (En%)), monounsaturated fatty acids (MUFA; > 10 En%), polyunsaturated fatty acids. (PUFA; approx. 10 En%), and long-chain n-3 PUFA (≥500 mg per day). (iv) measures to encourage consumption of vegetables and fruits, and. (v) eating more than 40 g dietary fiber every day. Half of the participants will be scheduled to consume an additional 3 g of long-chain n- 3 PUFA every day in the form of fish oil. The second component consists of regular one-on-one nutritional counseling, while a variety of further incentives make up the third component of the MoKaRi concept. The MoKaRi study will provide essential insights into the relationship between defined nutrient intake, markers of food intake and health status. Our specific aim is to investigate the influence of dietary and lifestyle choices have on cardiovascular health. The information and practical tools suitable for daily use, such as the personalized menu plans, could help to transfer knowledge on nutritional facts to the general population. In this way, the validated MoKaRi concept may contribute to the prevention and therapy of cardiovascular diseases. METHODS: In line with our power calculation, we will enroll 60 participants and randomly assign them to one of two parallel arms. Each participant will receive personalized menu plans for each day of the study and will be provided with one-on-one nutritional counseling sessions every two weeks for a study period of 20 weeks (140 days). During this period, blood samples will be taken every 14 days (11 time points) and twice during a 20-weeks follow-up period. Incentives such as a supply of foods approved according t the standards of the study, a sports program, individual feedback on study parameters reflecting health status, and group activities round off the MoKaRi concept. Low-density cholesterol is the primary outcome measure of the MoKaRi study, and the secondary endpoints comprise markers of nutrient status (e.g. fatty acid distribution in plasma and erythrocyte lipids), a metabolomic profiling, diabetes risk markers, clotting markers, and further cardiovascular risk factors, such as blood lipids, homocysteine and high-sensitive c-reactive protein. The MoKaRi study was registered before launch at ClinicalTrials.gov (identifier NCT02637778; https://clinicaltrials.gov/ct2/show/NCT02637778).