Back to resultsMoKaRi II Intervention Study (MoKaRi II)
Primary Purpose
Decreased Cardovascular Risk, Decreased Risk of Diabetes Mellitus Type II
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Menu plans
Sponsored by
About this trial
This is an interventional treatment trial for Decreased Cardovascular Risk focused on measuring triacylglcerides, glucose, HbA1c, body weight
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
Sites / Locations
- Institute of Nutritional Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Hypertriglyceridemia intervention (group A)
Hypertriglyceridemia control (group B)
Prediabetes intervention (group C)
Prediabetes control (group D)
Arm 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)
no menu plans, no study foods
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
no menu plans, no study foods
Outcomes
Primary Outcome Measures
Triacylglcerides, mmol/l (group A, B)
Cardiovascular risk factor
Fasting glucose, mmol/l (group C, D)
Diabetes risk factor
Secondary Outcome Measures
Total cholesterol (mmol/l)
Cardiovascular risk factor
HDL cholesterol (mmol/l)
Cardiovascular risk factor
LDL cholesterol (mmol/l)
Cardiovascular risk factor
Systolic pressure (mm Hg)
Cardiovascular risk factor
Diastolic pressure (mm Hg)
Cardiovascular risk factor
Insulin (mU/l)
Diabetes risk factor
HbA1c (%)
Diabetes risk factor
Body weight (kg)
Cardiovascular risk factor
Body fat (kg)
Cardiovascular risk factor
High sensitive c-reactive protein (mg/l)
Inflammatory marker
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)
Fatty acid distribution in erythrocyte lipids
Vitamin A (mmol/l)
Vitamins
Vitamin D (nmol/l)
Vitamins
Vitamin E (µmol/l)
Vitamins
Vitamin B1 (nmol/l)
Vitamins
Vitamin B6 (nmol/l)
Vitamins
Vitamin B12 (pmol/l)
Vitamins
Holo-transcobalamin (pmol/l)
Vitamins
Folic acid (µg/l)
Vitamins
Vitamin H (ng/l)
Vitamins
Vitamin C (mg/l)
Vitamins
Potassium (mmol/l)
Minerals and trace elements
Iron (µmol/l)
Minerals and trace elements
Ferritin (µg/l)
Minerals and trace elements
Transferrin (g/l)
Minerals and trace elements
Iodine (µmol/l)
Minerals and trace elements
Selenium (µmol/l)
Minerals and trace elements
Zinc (µmol/l)
Minerals and trace elements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05382533
Brief Title
MoKaRi II Intervention Study
Acronym
MoKaRi II
Official Title
Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decreased Cardovascular Risk, Decreased Risk of Diabetes Mellitus Type II
Keywords
triacylglcerides, glucose, HbA1c, body weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel design
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypertriglyceridemia intervention (group A)
Arm Type
Experimental
Arm 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)
Arm Title
Hypertriglyceridemia control (group B)
Arm Type
No Intervention
Arm Description
no menu plans, no study foods
Arm Title
Prediabetes intervention (group C)
Arm Type
Experimental
Arm 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
Arm Title
Prediabetes control (group D)
Arm Type
No Intervention
Arm Description
no menu plans, no study foods
Intervention Type
Dietary Supplement
Intervention Name(s)
Menu plans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triacylglcerides, mmol/l (group A, B)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
Fasting glucose, mmol/l (group C, D)
Description
Diabetes risk factor
Time Frame
Change from baseline after 10 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol (mmol/l)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
HDL cholesterol (mmol/l)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
LDL cholesterol (mmol/l)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
Systolic pressure (mm Hg)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
Diastolic pressure (mm Hg)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
Insulin (mU/l)
Description
Diabetes risk factor
Time Frame
Change from baseline after 10 weeks
Title
HbA1c (%)
Description
Diabetes risk factor
Time Frame
Change from baseline after 10 weeks
Title
Body weight (kg)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
Body fat (kg)
Description
Cardiovascular risk factor
Time Frame
Change from baseline after 10 weeks
Title
High sensitive c-reactive protein (mg/l)
Description
Inflammatory marker
Time Frame
Change from baseline after 10 weeks
Title
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)
Description
Fatty acid distribution in erythrocyte lipids
Time Frame
Change from baseline after 10 weeks
Title
Vitamin A (mmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin D (nmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin E (µmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin B1 (nmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin B6 (nmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin B12 (pmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Holo-transcobalamin (pmol/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Folic acid (µg/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin H (ng/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Vitamin C (mg/l)
Description
Vitamins
Time Frame
Change from baseline after 10 weeks
Title
Potassium (mmol/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Iron (µmol/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Ferritin (µg/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Transferrin (g/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Iodine (µmol/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Selenium (µmol/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Title
Zinc (µmol/l)
Description
Minerals and trace elements
Time Frame
Change from baseline after 10 weeks
Other Pre-specified Outcome Measures:
Title
Creatinine (mmol/l)
Description
Creatinine (24 h urine)
Time Frame
Change from baseline after 10 weeks
Title
Albumine (mg/l)
Description
Albumine (24 h urine)
Time Frame
Change from baseline after 10 weeks
Title
Selenium (µmol/24 h)
Description
Selenmium (24 h urine)
Time Frame
Change from baseline after 10 weeks
Title
Zinc (µmol/24 h)
Description
Zinc (24 h urine)
Time Frame
Change from baseline after 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A Dawczynski, PhD
Organizational Affiliation
Friedrich Schiller University Jena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutritional Sciences
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.nuco.uni-jena.de/studien
Description
Related Info
Learn more about this trial
MoKaRi II Intervention Study
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