MoKaRi II Intervention Study

University of Jena120 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Decreased Cardovascular Risk Decreased Risk of Diabetes Mellitus Type II

Interventions

Menu plansDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute of Nutritional Sciences

Jena, Thuringia, Germany