- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637778
Modulation of Cardiovascular Risk Factors by the Diet (MoKaRi-Diet)
Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardioprotective diet
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).
|
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.
|
Experimental: Cardioprotective diet + 3 g EPA+DHA/d
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). |
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood lipids
Time Frame: change from baseline at 20 weeks
|
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)
Time Frame: change from baseline at 20 weeks
|
Fatty acid distribution in plasma lipids und erythrocyte lipids [% FAME (fatty acid methyl ester)]
|
change from baseline at 20 weeks
|
insulin (blood)
Time Frame: change from baseline at 20 weeks
|
[units/ml]
|
change from baseline at 20 weeks
|
HbA1c (blood)
Time Frame: change from baseline at 20 weeks
|
change from baseline at 20 weeks
|
|
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]
|
change from baseline at 20 weeks
|
alpha prothrombin time (blood)
Time Frame: change from baseline at 20 weeks
|
[sec]
|
change from baseline at 20 weeks
|
fibrinogen (blood)
Time Frame: change from baseline at 20 weeks
|
[g/l]
|
change from baseline at 20 weeks
|
Nutritional status I (blood)
Time Frame: change from baseline at 20 weeks
|
vitamins (A, E), folic acid, iodine [µg/l]
|
change from baseline at 20 weeks
|
Nutritional status II (blood)
Time Frame: change from baseline at 20 weeks
|
vitamin D, vitamin B12 [pg/ml]
|
change from baseline at 20 weeks
|
Nutritional status III (blood)
Time Frame: change from baseline at 20 weeks
|
vitamin B1, B6 [ng/ml]
|
change from baseline at 20 weeks
|
homocysteine (blood)
Time Frame: change from baseline at 20 weeks
|
[µmmol/l]
|
change from baseline at 20 weeks
|
high sensitive c-reactive protein (blood)
Time Frame: change from baseline at 20 weeks
|
[mg/dl]
|
change from baseline at 20 weeks
|
lipoprotein(a) (blood)
Time Frame: change from baseline at 20 weeks
|
[mg/dl]
|
change from baseline at 20 weeks
|
height
Time Frame: change from baseline at 20 weeks
|
[m]
|
change from baseline at 20 weeks
|
weight
Time Frame: change from baseline at 20 weeks
|
[kg]
|
change from baseline at 20 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
apolipoproteins (blood)
Time Frame: change from baseline at 20 weeks
|
apolipoprotein A1, apolipoprotein B [g/l]
|
change from baseline at 20 weeks
|
adiponectin (blood)
Time Frame: change from baseline at 20 weeks
|
[mg/l]
|
change from baseline at 20 weeks
|
leptin, resistin (blood)
Time Frame: change from baseline at 20 weeks
|
[µg/l]
|
change from baseline at 20 weeks
|
creatinine (24h urine)
Time Frame: change from baseline at 20 weeks
|
[mmol/24h]
|
change from baseline at 20 weeks
|
albumin (24h urine)
Time Frame: change from baseline at 20 weeks
|
[mg/dl]
|
change from baseline at 20 weeks
|
Nutritional status IV (24h urine)
Time Frame: change from baseline at 20 weeks
|
natrium, magnesium (24h urine) [mmol/24h]
|
change from baseline at 20 weeks
|
Nutritional status V (24h urine)
Time Frame: change from baseline at 20 weeks
|
copper (24h urine) [µg/g creatinine]
|
change from baseline at 20 weeks
|
Nutritional status VI (24h urine)
Time Frame: change from baseline at 20 weeks
|
manganese (24h urine) [µg/l]
|
change from baseline at 20 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Dawczynski, PhD, University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany
- Principal Investigator: Stefan Lorkowski, PhD, University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2_16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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