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Cardiovascular DiseasesMoKaRi-DietNCT02637778

Modulation of Cardiovascular Risk Factors by the Diet

A study testing Cardioprotective diet and Cardioprotective diet + 3 g EPA + DHA/d in people with Cardiovascular Diseases, run by University of Jena.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Cardioprotective diet and Cardioprotective diet + 3 g EPA + DHA/d
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Feb 2016to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • LDL cholesterol ≥ 3 mmol/L

Who cannot join

  • 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

About this study

Official title: 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).

Read the 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.

Being tested
Cardioprotective diet, Cardioprotective diet + 3 g EPA + DHA/d
Keywords
nutrient profiles, menu plans, n-3 LC-PUFA, SFA, MUFA, PUFA, cardiovascular risk
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardioprotective dietDietary 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/dDietary 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)

Study groups in NCT02637778
Study groupRoleWhat they receive
Cardioprotective dietExperimentalThe 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).
Receives: Dietary Supplement: Cardioprotective diet
Cardioprotective diet + 3 g EPA+DHA/dExperimentalThe 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).
Receives: Dietary Supplement: Cardioprotective diet + 3 g EPA + DHA/d

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood lipids

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

    Measured: change from baseline at 20 weeks

Secondary outcomes (14)

  1. fatty acid distribution (blood)

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

    Measured: change from baseline at 20 weeks

  2. insulin (blood)

    [units/ml]

    Measured: change from baseline at 20 weeks

  3. HbA1c (blood)

    Measured: change from baseline at 20 weeks

  4. oral glucose tolerance test (blood)

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

    Measured: change from baseline at 20 weeks

  5. alpha prothrombin time (blood)

    [sec]

    Measured: change from baseline at 20 weeks

  6. fibrinogen (blood)

    [g/l]

    Measured: change from baseline at 20 weeks

  7. Nutritional status I (blood)

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

    Measured: change from baseline at 20 weeks

  8. Nutritional status II (blood)

    vitamin D, vitamin B12 [pg/ml]

    Measured: change from baseline at 20 weeks

  9. Nutritional status III (blood)

    vitamin B1, B6 [ng/ml]

    Measured: change from baseline at 20 weeks

  10. homocysteine (blood)

    [µmmol/l]

    Measured: change from baseline at 20 weeks

  11. high sensitive c-reactive protein (blood)

    [mg/dl]

    Measured: change from baseline at 20 weeks

  12. lipoprotein(a) (blood)

    [mg/dl]

    Measured: change from baseline at 20 weeks

  13. height

    [m]

    Measured: change from baseline at 20 weeks

  14. weight

    [kg]

    Measured: change from baseline at 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionJun 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02637778
Sponsor's protocol ID
H2_16
Acronym
MoKaRi-Diet
Status last verified
Feb 2023
First submitted
15 Dec 2015
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
No

Publications

  • Dawczynski C, Drobner T, Weidauer T, Schlattmann P, Kiehntopf M, Weber D, Grune T, Marz W, Kleber ME, Lorkowski S. Reduction of cardiovascular risk factors by the diet - Evaluation of the MoKaRi concept by a parallel-designed randomized study. Lipids Health Dis. 2025 Mar 8;24(1):88. doi: 10.1186/s12944-025-02500-1.

    PubMed 40057729

  • Dawczynski C, Cullen PM, Schlattmann P, Lorkowski S. A study protocol of a randomized trial evaluating the effect of using defined menu plans within an intensive personal nutritional counseling program on cardiovascular risk factors: The MoKaRi (modulation of cardiovascular risk factors) trial. Contemp Clin Trials Commun. 2021 Apr 29;22:100761. doi: 10.1016/j.conctc.2021.100761. eCollection 2021 Jun.

    PubMed 33997459

Questions about this trial

What is this clinical trial studying?

A study testing Cardioprotective diet and Cardioprotective diet + 3 g EPA + DHA/d in people with Cardiovascular Diseases, run by University of Jena.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood lipids (time frame: change from baseline at 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02637778, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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