Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments cardioprotective diet, cardioprotective diet + 3 g epa + dha/d
Sponsor University of Jena
Collaborator German Federal Ministry of Education and Research
Start date February 2016
End date June 2016
Trial size 60 participants
Trial identifier NCT02637778, H2_16

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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).
cardioprotective diet
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)
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).
cardioprotective diet + 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)

Primary Outcomes

Measure
blood lipids
time frame: change from baseline at 20 weeks

Secondary Outcomes

Measure
fatty acid distribution (blood)
time frame: change from baseline at 20 weeks
insulin (blood)
time frame: change from baseline at 20 weeks
HbA1c (blood)
time frame: change from baseline at 20 weeks
oral glucose tolerance test (blood)
time frame: change from baseline at 20 weeks
alpha prothrombin time (blood)
time frame: change from baseline at 20 weeks
fibrinogen (blood)
time frame: change from baseline at 20 weeks
Nutritional status I (blood)
time frame: change from baseline at 20 weeks
Nutritional status II (blood)
time frame: change from baseline at 20 weeks
Nutritional status III (blood)
time frame: change from baseline at 20 weeks
homocysteine (blood)
time frame: change from baseline at 20 weeks
high sensitive c-reactive protein (blood)
time frame: change from baseline at 20 weeks
lipoprotein(a) (blood)
time frame: change from baseline at 20 weeks
height
time frame: change from baseline at 20 weeks
weight
time frame: change from baseline at 20 weeks

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans
Principal investigator Christine Dawczynski, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Jena.