Cardiovascular Diseases
Conditions
Keywords
nutrient profiles, menu plans, n-3 LC-PUFA, SFA, MUFA, PUFA, cardiovascular risk
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTCardioprotective diet
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.
DIETARY_SUPPLEMENTCardioprotective diet + 3 g EPA + DHA/d
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)
Sponsors
German Federal Ministry of Education and Research
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood lipids | change from baseline at 20 weeks | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) \[mmol/L\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oral glucose tolerance test (blood) | change from baseline at 20 weeks | blood glucose (timepoints: 0, 60 min, 120 min) after oral challenge (75 g glucose) \[mmol/l\] |
| Nutritional status I (blood) | change from baseline at 20 weeks | vitamins (A, E), folic acid, iodine \[µg/l\] |
| Nutritional status II (blood) | change from baseline at 20 weeks | vitamin D, vitamin B12 \[pg/ml\] |
| Nutritional status III (blood) | change from baseline at 20 weeks | vitamin B1, B6 \[ng/ml\] |
| homocysteine (blood) | change from baseline at 20 weeks | \[µmmol/l\] |
| high sensitive c-reactive protein (blood) | change from baseline at 20 weeks | \[mg/dl\] |
| lipoprotein(a) (blood) | change from baseline at 20 weeks | \[mg/dl\] |
| height | change from baseline at 20 weeks | \[m\] |
| weight | change from baseline at 20 weeks | \[kg\] |
| fatty acid distribution (blood) | change from baseline at 20 weeks | Fatty acid distribution in plasma lipids und erythrocyte lipids \[% FAME (fatty acid methyl ester)\] |
| insulin (blood) | change from baseline at 20 weeks | \[units/ml\] |
| HbA1c (blood) | change from baseline at 20 weeks | — |
| alpha prothrombin time (blood) | change from baseline at 20 weeks | \[sec\] |
| fibrinogen (blood) | change from baseline at 20 weeks | \[g/l\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| leptin, resistin (blood) | change from baseline at 20 weeks | \[µg/l\] |
| creatinine (24h urine) | change from baseline at 20 weeks | \[mmol/24h\] |
| albumin (24h urine) | change from baseline at 20 weeks | \[mg/dl\] |
| Nutritional status IV (24h urine) | change from baseline at 20 weeks | natrium, magnesium (24h urine) \[mmol/24h\] |
| Nutritional status V (24h urine) | change from baseline at 20 weeks | copper (24h urine) \[µg/g creatinine\] |
| Nutritional status VI (24h urine) | change from baseline at 20 weeks | manganese (24h urine) \[µg/l\] |
| adiponectin (blood) | change from baseline at 20 weeks | \[mg/l\] |
| apolipoproteins (blood) | change from baseline at 20 weeks | apolipoprotein A1, apolipoprotein B \[g/l\] |
Outcome results
None listed