NCT02637778

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

December 15, 2015

Last Update Submit

February 18, 2023

Conditions

Cardiovascular Diseases

Keywords

nutrient profilesmenu plansn-3 LC-PUFASFAMUFAPUFAcardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • blood lipids

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

    change from baseline at 20 weeks

Secondary Outcomes (14)

  • fatty acid distribution (blood)

    change from baseline at 20 weeks

  • insulin (blood)

    change from baseline at 20 weeks

  • HbA1c (blood)

    change from baseline at 20 weeks

  • oral glucose tolerance test (blood)

    change from baseline at 20 weeks

  • alpha prothrombin time (blood)

    change from baseline at 20 weeks

  • +9 more secondary outcomes

Other Outcomes (8)

  • apolipoproteins (blood)

    change from baseline at 20 weeks

  • adiponectin (blood)

    change from baseline at 20 weeks

  • leptin, resistin (blood)

    change from baseline at 20 weeks

  • +5 more other outcomes

Study Arms (2)

Cardioprotective diet

EXPERIMENTAL

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).

Dietary Supplement: Cardioprotective diet

Cardioprotective diet + 3 g EPA+DHA/d

EXPERIMENTAL

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).

Dietary Supplement: Cardioprotective diet + 3 g EPA + DHA/d

Interventions

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
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)

Cardioprotective diet + 3 g EPA+DHA/d

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- LDL cholesterol ≥ 3 mmol/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 40057729DERIVED

  • 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.

    PMID: 33997459DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 22, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

February 22, 2023

Record last verified: 2023-02