MoKaRi II Intervention Study

University of Jena

Status: Completed

Conditions: Decreased Risk of Diabetes Mellitus Type II; Decreased Cardovascular Risk

Treatments: Dietary Supplement: Menu plans

Study type: Interventional

Funder types: Other

Identifiers

NCT05382533

H13-22

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Hypertriglyceridemia intervention (group A)

Experimental group

Description:

* 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)

Treatment:

Dietary Supplement: Menu plans

Hypertriglyceridemia control (group B)

No Intervention group

Description:

no menu plans, no study foods

Prediabetes intervention (group C)

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Menu plans

Prediabetes control (group D)

No Intervention group

Description:

no menu plans, no study foods