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Completed

NCT Number: NCT02637778

Modulation of Cardiovascular Risk Factors by the Diet

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).

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Key information

Conditions

Cardiovascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioprotective diet

Dietary Supplement

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.

Cardioprotective diet + 3 g EPA + DHA/d

Dietary Supplement

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)

Primary outcomes

  1. blood lipids

    Time frame: change from baseline at 20 weeks

    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]

Secondary outcomes

  1. fatty acid distribution (blood)

    Time frame: change from baseline at 20 weeks

    Fatty acid distribution in plasma lipids und erythrocyte lipids [% FAME (fatty acid methyl ester)]

  2. insulin (blood)

    Time frame: change from baseline at 20 weeks

    [units/ml]

  3. HbA1c (blood)

    Time frame: change from baseline at 20 weeks

  4. oral glucose tolerance test (blood)

    Time frame: change from baseline at 20 weeks

    blood glucose (timepoints: 0, 60 min, 120 min) after oral challenge (75 g glucose) [mmol/l]

  5. alpha prothrombin time (blood)

    Time frame: change from baseline at 20 weeks

    [sec]

  6. fibrinogen (blood)

    Time frame: change from baseline at 20 weeks

    [g/l]

  7. Nutritional status I (blood)

    Time frame: change from baseline at 20 weeks

    vitamins (A, E), folic acid, iodine [µg/l]

  8. Nutritional status II (blood)

    Time frame: change from baseline at 20 weeks

    vitamin D, vitamin B12 [pg/ml]

  9. Nutritional status III (blood)

    Time frame: change from baseline at 20 weeks

    vitamin B1, B6 [ng/ml]

  10. homocysteine (blood)

    Time frame: change from baseline at 20 weeks

    [µmmol/l]

  11. high sensitive c-reactive protein (blood)

    Time frame: change from baseline at 20 weeks

    [mg/dl]

  12. lipoprotein(a) (blood)

    Time frame: change from baseline at 20 weeks

    [mg/dl]

  13. height

    Time frame: change from baseline at 20 weeks

    [m]

  14. weight

    Time frame: change from baseline at 20 weeks

    [kg]

Other outcomes

  1. apolipoproteins (blood)

    Time frame: change from baseline at 20 weeks

    apolipoprotein A1, apolipoprotein B [g/l]

  2. adiponectin (blood)

    Time frame: change from baseline at 20 weeks

    [mg/l]

  3. leptin, resistin (blood)

    Time frame: change from baseline at 20 weeks

    [µg/l]

  4. creatinine (24h urine)

    Time frame: change from baseline at 20 weeks

    [mmol/24h]

  5. albumin (24h urine)

    Time frame: change from baseline at 20 weeks

    [mg/dl]

  6. Nutritional status IV (24h urine)

    Time frame: change from baseline at 20 weeks

    natrium, magnesium (24h urine) [mmol/24h]

  7. Nutritional status V (24h urine)

    Time frame: change from baseline at 20 weeks

    copper (24h urine) [µg/g creatinine]

  8. Nutritional status VI (24h urine)

    Time frame: change from baseline at 20 weeks

    manganese (24h urine) [µg/l]

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: MoKaRi-Diet

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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