Clinical trial NCT02637778: Modulation of Cardiovascular Risk Factors by the Diet
Official title: Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: nutrient profiles
menu plans
n-3 LC-PUFA
SFA
MUFA
PUFA
cardiovascular risk
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2015-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood lipids
timeFrame: change from baseline at 20 weeks
Secondary outcomes:
measure: fatty acid distribution (blood)
timeFrame: change from baseline at 20 weeks
measure: insulin (blood)
timeFrame: change from baseline at 20 weeks
measure: HbA1c (blood)
timeFrame: change from baseline at 20 weeks
measure: oral glucose tolerance test (blood)
timeFrame: change from baseline at 20 weeks
measure: alpha prothrombin time (blood)
timeFrame: change from baseline at 20 weeks
measure: fibrinogen (blood)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status I (blood)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status II (blood)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status III (blood)
timeFrame: change from baseline at 20 weeks
measure: homocysteine (blood)
timeFrame: change from baseline at 20 weeks
measure: high sensitive c-reactive protein (blood)
timeFrame: change from baseline at 20 weeks
measure: lipoprotein(a) (blood)
timeFrame: change from baseline at 20 weeks
measure: height
timeFrame: change from baseline at 20 weeks
measure: weight
timeFrame: change from baseline at 20 weeks
Other outcomes:
measure: apolipoproteins (blood)
timeFrame: change from baseline at 20 weeks
measure: adiponectin (blood)
timeFrame: change from baseline at 20 weeks
measure: leptin, resistin (blood)
timeFrame: change from baseline at 20 weeks
measure: creatinine (24h urine)
timeFrame: change from baseline at 20 weeks
measure: albumin (24h urine)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status IV (24h urine)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status V (24h urine)
timeFrame: change from baseline at 20 weeks
measure: Nutritional status VI (24h urine)
timeFrame: change from baseline at 20 weeks
Locations:
Study officials:
affiliation: University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany
name: Stefan Lorkowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.