Modulation of Cardiovascular Risk Factors by the Diet
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): Cardioprotective diet; Cardioprotective diet + 3 g EPA + DHA/d
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nutrient profiles; menu plans; n-3 LC-PUFA; SFA; MUFA; PUFA; cardiovascular risk