Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Decreased Cardovascular Risk
- Sponsor
- University of Jena
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Triacylglcerides, mmol/l (group A, B)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7 mmol/l).
Detailed Description
The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance (glucose \> 5.6 ≤ 7 mmol/l). The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D). The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products. Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D). The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.
Investigators
Christine Dawczynski,PhD
PhD
University of Jena
Eligibility Criteria
Inclusion Criteria
- •Voluntary participation with documented consent
- •Willingness and ability to adhere to study protocol
- •Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
- •BMI: ≥ 20 ≤ 40 kg/m2
- •No or moderate alcohol consumption (≤ 2 glasses/week)
- •non-smoker (if possible)
- •Group A, B: triglycerides: \> 1.5 mmol/l
- •Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L
Exclusion Criteria
- •Concomitant diseases:
- •Hypercholesterolemia (genetic defect / familial predisposition)
- •Diabetes mellitus
- •Thyroid dysfunction (hyper- or hypothyroidism)
- •Food intolerances/allergies to ingredients in the study foods
- •Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
- •Dietary supplements: especially n-3 fatty acids, vitamin E
- •Extremely high physical activity (daily)
- •Alcohol abuse (daily)
- •(smokers) \[if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible\]
Outcomes
Primary Outcomes
Triacylglcerides, mmol/l (group A, B)
Time Frame: Change from baseline after 10 weeks
Cardiovascular risk factor
Fasting glucose, mmol/l (group C, D)
Time Frame: Change from baseline after 10 weeks
Diabetes risk factor
Secondary Outcomes
- High sensitive c-reactive protein (mg/l)(Change from baseline after 10 weeks)
- Vitamin B6 (nmol/l)(Change from baseline after 10 weeks)
- Vitamin B12 (pmol/l)(Change from baseline after 10 weeks)
- Selenium (µmol/l)(Change from baseline after 10 weeks)
- Total cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Diastolic pressure (mm Hg)(Change from baseline after 10 weeks)
- Vitamin A (mmol/l)(Change from baseline after 10 weeks)
- Vitamin B1 (nmol/l)(Change from baseline after 10 weeks)
- Vitamin H (ng/l)(Change from baseline after 10 weeks)
- HDL cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Systolic pressure (mm Hg)(Change from baseline after 10 weeks)
- Insulin (mU/l)(Change from baseline after 10 weeks)
- LDL cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Folic acid (µg/l)(Change from baseline after 10 weeks)
- HbA1c (%)(Change from baseline after 10 weeks)
- Body fat (kg)(Change from baseline after 10 weeks)
- Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)(Change from baseline after 10 weeks)
- Vitamin C (mg/l)(Change from baseline after 10 weeks)
- Body weight (kg)(Change from baseline after 10 weeks)
- Vitamin D (nmol/l)(Change from baseline after 10 weeks)
- Vitamin E (µmol/l)(Change from baseline after 10 weeks)
- Holo-transcobalamin (pmol/l)(Change from baseline after 10 weeks)
- Potassium (mmol/l)(Change from baseline after 10 weeks)
- Iron (µmol/l)(Change from baseline after 10 weeks)
- Ferritin (µg/l)(Change from baseline after 10 weeks)
- Transferrin (g/l)(Change from baseline after 10 weeks)
- Iodine (µmol/l)(Change from baseline after 10 weeks)
- Zinc (µmol/l)(Change from baseline after 10 weeks)