MoKaRi II Intervention Study

NCT ID: NCT05382533

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-12-14

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.

Conditions

Decreased Cardovascular Risk; Decreased Risk of Diabetes Mellitus Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypertriglyceridemia intervention (group A)

• 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)

Group Type: EXPERIMENTAL

Menu plans

Intervention Type: DIETARY_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.

Hypertriglyceridemia control (group B)

no menu plans, no study foods

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prediabetes intervention (group C)

• 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

Group Type: EXPERIMENTAL

Menu plans

Intervention Type: DIETARY_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.

Prediabetes control (group D)

no menu plans, no study foods

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Menu plans

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.

Intervention Type: DIETARY_SUPPLEMENT

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]
• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Christine Dawczynski,PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine A Dawczynski, PhD

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller University Jena

Locations

Institute of Nutritional Sciences

Jena, Thuringia, Germany

Countries

Germany

Related Links

https://www.nuco.uni-jena.de/studien

Related Info

Other Identifiers

H13-22

Identifier Type: -

Identifier Source: org_study_id