Modulation of Cardiovascular Risk Factors by the Diet (MoKaRi-Diet)

February 18, 2023 updated by: Christine Dawczynski,PhD, University of Jena

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

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 18, 2023

Last Verified

February 1, 2023

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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