Modulation of Cardiovascular Risk Factors by the Diet

Cardiovascular Diseases Clinical Trial

— MoKaRi-Diet  

Official title:

Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637778
• Other study ID #: H2_16
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2016

Study information

• Verified date: February 2023
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• 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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	apolipoproteins (blood)	apolipoprotein A1, apolipoprotein B [g/l]	change from baseline at 20 weeks
Other	adiponectin (blood)	[mg/l]	change from baseline at 20 weeks
Other	leptin, resistin (blood)	[µg/l]	change from baseline at 20 weeks
Other	creatinine (24h urine)	[mmol/24h]	change from baseline at 20 weeks
Other	albumin (24h urine)	[mg/dl]	change from baseline at 20 weeks
Other	Nutritional status IV (24h urine)	natrium, magnesium (24h urine) [mmol/24h]	change from baseline at 20 weeks
Other	Nutritional status V (24h urine)	copper (24h urine) [µg/g creatinine]	change from baseline at 20 weeks
Other	Nutritional status VI (24h urine)	manganese (24h urine) [µg/l]	change from baseline at 20 weeks
Primary	blood lipids	total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]	change from baseline at 20 weeks
Secondary	fatty acid distribution (blood)	Fatty acid distribution in plasma lipids und erythrocyte lipids [% FAME (fatty acid methyl ester)]	change from baseline at 20 weeks
Secondary	insulin (blood)	[units/ml]	change from baseline at 20 weeks
Secondary	HbA1c (blood)		change from baseline at 20 weeks
Secondary	oral glucose tolerance test (blood)	blood glucose (timepoints: 0, 60 min, 120 min) after oral challenge (75 g glucose) [mmol/l]	change from baseline at 20 weeks
Secondary	alpha prothrombin time (blood)	[sec]	change from baseline at 20 weeks
Secondary	fibrinogen (blood)	[g/l]	change from baseline at 20 weeks
Secondary	Nutritional status I (blood)	vitamins (A, E), folic acid, iodine [µg/l]	change from baseline at 20 weeks
Secondary	Nutritional status II (blood)	vitamin D, vitamin B12 [pg/ml]	change from baseline at 20 weeks
Secondary	Nutritional status III (blood)	vitamin B1, B6 [ng/ml]	change from baseline at 20 weeks
Secondary	homocysteine (blood)	[µmmol/l]	change from baseline at 20 weeks
Secondary	high sensitive c-reactive protein (blood)	[mg/dl]	change from baseline at 20 weeks
Secondary	lipoprotein(a) (blood)	[mg/dl]	change from baseline at 20 weeks
Secondary	height	[m]	change from baseline at 20 weeks
Secondary	weight	[kg]	change from baseline at 20 weeks

External Links

•   Study protocoll
•   Study results