Modulation of Cardiovascular Risk Factors by the Diet

Study Overview
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Brief Summary
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The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by adequate energy intake, intake of carbohydrates, protein and fat according to the guidelines of the German Society of Nutrition (DGE e. V.), with special focus on fat quality of the foods. Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).

Detailed Description
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The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity. Half of the participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks). Besides the personal dialogues participants receive information materials providing the dietary recommendations, information to improve nutritional behavior and environment as well as various practical advices. Additionally, a weekly reminder strengthens the approach in addition to each visit at a 2-week interval. The reflection about the implementation of the advices within day-to-day routine and the resulting challenges are an important part of the concept (feedback). The identification of variables influencing people's nutritional behavior is attained and offers the possibility to address these variables within the recommendations that will be developed for adults with increased CVD risk as part of our nutriCARD strategy (Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany). The study will provide data about the association between the defined dietary intake and measurable markers reflecting food intake (nutritional biomarkers) as well as expression of cardiovascular biomarkers.

Official Title
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Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Cardioprotective diet
* Dietary Supplement: Cardioprotective diet + 3 g EPA + DHA/d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - LDL cholesterol ≥ 3 mmol/L Exclusion Criteria: intake of lipid-lowering medications gastrointestinal diseases familial hypercholesterolemia intake of additional dietary supplements (especially fish oil capsules or vitamin E) pregnancy, lactation patient's request or if patient compliance with the study protocol is doubtful

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioprotective diet<br>The study participants receive defined personal nutrition counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 wks (follow-up 20 wks). | Dietary Supplement: Cardioprotective diet<br>* The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.<br>|
| Experimental: Cardioprotective diet + 3 g EPA+DHA/d<br>The study participants receive defined personal nutrition counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 wks (follow-up 20 wks). Participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d). | Dietary Supplement: Cardioprotective diet + 3 g EPA + DHA/d<br>* The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.The participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood lipids | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | change from baseline at 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatty acid distribution (blood) | Fatty acid distribution in plasma lipids und erythrocyte lipids [% FAME (fatty acid methyl ester)] | change from baseline at 20 weeks | 
| insulin (blood) | [units/ml] | change from baseline at 20 weeks | 
| HbA1c (blood) |  | change from baseline at 20 weeks | 
| oral glucose tolerance test (blood) | blood glucose (timepoints: 0, 60 min, 120 min) after oral challenge (75 g glucose) [mmol/l] | change from baseline at 20 weeks | 
| alpha prothrombin time (blood) | [sec] | change from baseline at 20 weeks | 
| fibrinogen (blood) | [g/l] | change from baseline at 20 weeks | 
| Nutritional status I (blood) | vitamins (A, E), folic acid, iodine [µg/l] | change from baseline at 20 weeks | 
| Nutritional status II (blood) | vitamin D, vitamin B12 [pg/ml] | change from baseline at 20 weeks | 
| Nutritional status III (blood) | vitamin B1, B6 [ng/ml] | change from baseline at 20 weeks | 
| homocysteine (blood) | [µmmol/l] | change from baseline at 20 weeks | 
| high sensitive c-reactive protein (blood) | [mg/dl] | change from baseline at 20 weeks | 
| lipoprotein(a) (blood) | [mg/dl] | change from baseline at 20 weeks | 
| height | [m] | change from baseline at 20 weeks | 
| weight | [kg] | change from baseline at 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUFA, nutrient profiles, menu plans, n-3 LC-PUFA, SFA, PUFA, cardiovascular risk