MoKaRi II Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans

Conditions
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Decreased Cardovascular Risk, Decreased Risk of Diabetes Mellitus Type II

Intervention / Treatment
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* Dietary Supplement: Menu plans


Participation Criteria
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Eligibility Criteria
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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] 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertriglyceridemia intervention (group A)<br>Carbohydrates: ≤ 50 en% (sucrose + glucose + fructose ≤ 10 en%, where sucrose ≤ 5 en% and fructose ≤ 20 g/d) Fat: 30-35 En% Protein: 20 En% marine n3 PUFA (EPA/DHA): ≥ 4000 mg/d (10 g fish oil) | Dietary Supplement: Menu plans<br>* 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 (plant oils, nuts mixture etc.) over the study period of 10 weeks.<br>|
| No Intervention: Hypertriglyceridemia control (group B)<br>no menu plans, no study foods | |
| Experimental: Prediabetes intervention (group C)<br>Carbohydrates: 40 ± 2 En% Sucrose + glucose + fructose ≤ 10 En% Free sugars < 5% of daily energy Fat: 40 ± 2% Protein: 20 ± 2 En% n3 PUFA: ≥ 500 mg/d | Dietary Supplement: Menu plans<br>* 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 (plant oils, nuts mixture etc.) over the study period of 10 weeks.<br>|
| No Intervention: Prediabetes control (group D)<br>no menu plans, no study foods | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triacylglcerides, mmol/l (group A, B) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| Fasting glucose, mmol/l (group C, D) | Diabetes risk factor | Change from baseline after 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol (mmol/l) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| HDL cholesterol (mmol/l) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| LDL cholesterol (mmol/l) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| Systolic pressure (mm Hg) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| Diastolic pressure (mm Hg) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| Insulin (mU/l) | Diabetes risk factor | Change from baseline after 10 weeks | 
| HbA1c (%) | Diabetes risk factor | Change from baseline after 10 weeks | 
| Body weight (kg) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| Body fat (kg) | Cardiovascular risk factor | Change from baseline after 10 weeks | 
| High sensitive c-reactive protein (mg/l) | Inflammatory marker | Change from baseline after 10 weeks | 
| Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters) | Fatty acid distribution in erythrocyte lipids | Change from baseline after 10 weeks | 
| Vitamin A (mmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin D (nmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin E (µmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin B1 (nmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin B6 (nmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin B12 (pmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Holo-transcobalamin (pmol/l) | Vitamins | Change from baseline after 10 weeks | 
| Folic acid (µg/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin H (ng/l) | Vitamins | Change from baseline after 10 weeks | 
| Vitamin C (mg/l) | Vitamins | Change from baseline after 10 weeks | 
| Potassium (mmol/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Iron (µmol/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Ferritin (µg/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Transferrin (g/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Iodine (µmol/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Selenium (µmol/l) | Minerals and trace elements | Change from baseline after 10 weeks | 
| Zinc (µmol/l) | Minerals and trace elements | Change from baseline after 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triacylglcerides, glucose, HbA1c, body weight