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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 '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)
blood lipids
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) \[mmol/L\]
Time frame: change from baseline at 20 weeks
fatty acid distribution (blood)
Fatty acid distribution in plasma lipids und erythrocyte lipids \[% FAME (fatty acid methyl ester)\]
Time frame: change from baseline at 20 weeks
insulin (blood)
\[units/ml\]
Time frame: change from baseline at 20 weeks
HbA1c (blood)
Time frame: 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) \[mmol/l\]
Time frame: change from baseline at 20 weeks
alpha prothrombin time (blood)
\[sec\]
Time frame: change from baseline at 20 weeks
fibrinogen (blood)
\[g/l\]
Time frame: change from baseline at 20 weeks
Nutritional status I (blood)
vitamins (A, E), folic acid, iodine \[µg/l\]
Time frame: change from baseline at 20 weeks
Nutritional status II (blood)
vitamin D, vitamin B12 \[pg/ml\]
Time frame: change from baseline at 20 weeks
Nutritional status III (blood)
vitamin B1, B6 \[ng/ml\]
Time frame: change from baseline at 20 weeks
homocysteine (blood)
\[µmmol/l\]
Time frame: change from baseline at 20 weeks
high sensitive c-reactive protein (blood)
\[mg/dl\]
Time frame: change from baseline at 20 weeks
lipoprotein(a) (blood)
\[mg/dl\]
Time frame: change from baseline at 20 weeks
height
\[m\]
Time frame: change from baseline at 20 weeks
weight
\[kg\]
Time frame: change from baseline at 20 weeks
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