Clinical trial NCT05382533: MoKaRi II Intervention Study
Official title: Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decreased Cardovascular Risk
Decreased Risk of Diabetes Mellitus Type II
Keywords: triacylglcerides, glucose, HbA1c, body weight
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Triacylglcerides, mmol/l (group A, B)
timeFrame: Change from baseline after 10 weeks
measure: Fasting glucose, mmol/l (group C, D)
timeFrame: Change from baseline after 10 weeks
Secondary outcomes:
measure: Total cholesterol (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: HDL cholesterol (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: LDL cholesterol (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Systolic pressure (mm Hg)
timeFrame: Change from baseline after 10 weeks
measure: Diastolic pressure (mm Hg)
timeFrame: Change from baseline after 10 weeks
measure: Insulin (mU/l)
timeFrame: Change from baseline after 10 weeks
measure: HbA1c (%)
timeFrame: Change from baseline after 10 weeks
measure: Body weight (kg)
timeFrame: Change from baseline after 10 weeks
measure: Body fat (kg)
timeFrame: Change from baseline after 10 weeks
measure: High sensitive c-reactive protein (mg/l)
timeFrame: Change from baseline after 10 weeks
measure: Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin A (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin D (nmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin E (µmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin B1 (nmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin B6 (nmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin B12 (pmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Holo-transcobalamin (pmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Folic acid (µg/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin H (ng/l)
timeFrame: Change from baseline after 10 weeks
measure: Vitamin C (mg/l)
timeFrame: Change from baseline after 10 weeks
measure: Potassium (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Iron (µmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Ferritin (µg/l)
timeFrame: Change from baseline after 10 weeks
measure: Transferrin (g/l)
timeFrame: Change from baseline after 10 weeks
measure: Iodine (µmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Selenium (µmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Zinc (µmol/l)
timeFrame: Change from baseline after 10 weeks
Other outcomes:
measure: Creatinine (mmol/l)
timeFrame: Change from baseline after 10 weeks
measure: Albumine (mg/l)
timeFrame: Change from baseline after 10 weeks
measure: Selenium (µmol/24 h)
timeFrame: Change from baseline after 10 weeks
measure: Zinc (µmol/24 h)
timeFrame: Change from baseline after 10 weeks
Locations:
city: Jena
country: Germany
facility: Institute of Nutritional Sciences
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena
name: Christine A Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References: