MoKaRi II Intervention Study (MoKaRi II)

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

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).

Study Overview

• Status: Completed
• Conditions: Decreased Cardovascular Risk; Decreased Risk of Diabetes Mellitus Type II
• Intervention / Treatment: Dietary supplement: Menu plans

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Institute of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Dietary supplement: 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.
NO_INTERVENTION: Hypertriglyceridemia control (group B); no menu plans, no study foods
EXPERIMENTAL: 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	Dietary supplement: 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.
NO_INTERVENTION: Prediabetes control (group D); no menu plans, no study foods

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine (mmol/l)	Creatinine (24 h urine)	Change from baseline after 10 weeks
Albumine (mg/l)	Albumine (24 h urine)	Change from baseline after 10 weeks
Selenium (µmol/24 h)	Selenmium (24 h urine)	Change from baseline after 10 weeks
Zinc (µmol/24 h)	Zinc (24 h urine)	Change from baseline after 10 weeks

Collaborators and Investigators

• Sponsor: University of Jena
• Investigators: Principal Investigator: Christine A Dawczynski, PhD, Friedrich Schiller University Jena

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2022
• Primary Completion (ACTUAL): August 31, 2022
• Study Completion (ACTUAL): December 14, 2022

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (ACTUAL): May 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: triacylglcerides, glucose, HbA1c, body weight
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H13-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No