MoKaRi II Intervention Study
- Conditions
- Decreased Cardovascular RiskDecreased Risk of Diabetes Mellitus Type II
- Registration Number
- NCT05382533
- Lead Sponsor
- University of Jena
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
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]
- Uncontrolled organic diseases
- Alcohol, medication or drug abuse
- Participation in other observational clinical studies during or 4 wk. before starting this study
- Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance
- Pregnancy, lactation and unsafe contraception
- Other reasons considered important by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Triacylglcerides, mmol/l (group A, B) Change from baseline after 10 weeks Cardiovascular risk factor
Fasting glucose, mmol/l (group C, D) Change from baseline after 10 weeks Diabetes risk factor
- Secondary Outcome Measures
Name Time Method Insulin (mU/l) Change from baseline after 10 weeks Diabetes risk factor
Body weight (kg) Change from baseline after 10 weeks Cardiovascular risk factor
Vitamin D (nmol/l) Change from baseline after 10 weeks Vitamins
Vitamin E (µmol/l) Change from baseline after 10 weeks Vitamins
Iron (µmol/l) Change from baseline after 10 weeks Minerals and trace elements
Ferritin (µg/l) Change from baseline after 10 weeks Minerals and trace elements
Transferrin (g/l) Change from baseline after 10 weeks Minerals and trace elements
High sensitive c-reactive protein (mg/l) Change from baseline after 10 weeks Inflammatory marker
Vitamin B6 (nmol/l) Change from baseline after 10 weeks Vitamins
Vitamin B12 (pmol/l) Change from baseline after 10 weeks Vitamins
Selenium (µmol/l) Change from baseline after 10 weeks Minerals and trace elements
Total cholesterol (mmol/l) Change from baseline after 10 weeks Cardiovascular risk factor
Diastolic pressure (mm Hg) Change from baseline after 10 weeks Cardiovascular risk factor
Vitamin A (mmol/l) Change from baseline after 10 weeks Vitamins
Vitamin B1 (nmol/l) Change from baseline after 10 weeks Vitamins
HDL cholesterol (mmol/l) Change from baseline after 10 weeks Cardiovascular risk factor
Systolic pressure (mm Hg) Change from baseline after 10 weeks Cardiovascular risk factor
LDL cholesterol (mmol/l) Change from baseline after 10 weeks Cardiovascular risk factor
Folic acid (µg/l) Change from baseline after 10 weeks Vitamins
HbA1c (%) Change from baseline after 10 weeks Diabetes risk factor
Body fat (kg) Change from baseline after 10 weeks Cardiovascular risk factor
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters) Change from baseline after 10 weeks Fatty acid distribution in erythrocyte lipids
Vitamin C (mg/l) Change from baseline after 10 weeks Vitamins
Holo-transcobalamin (pmol/l) Change from baseline after 10 weeks Vitamins
Potassium (mmol/l) Change from baseline after 10 weeks Minerals and trace elements
Iodine (µmol/l) Change from baseline after 10 weeks Minerals and trace elements
Zinc (µmol/l) Change from baseline after 10 weeks Minerals and trace elements
Vitamin H (ng/l) Change from baseline after 10 weeks Vitamins
Trial Locations
- Locations (1)
Institute of Nutritional Sciences
🇩🇪Jena, Thuringia, Germany
Institute of Nutritional Sciences🇩🇪Jena, Thuringia, Germany