Status:
COMPLETED
MoKaRi II Intervention Study
Lead Sponsor:
University of Jena
Conditions:
Decreased Cardovascular Risk
Decreased Risk of Diabetes Mellitus Type II
Eligibility:
All Genders
30-80 years
Phase:
NA
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 participan...
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 glu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05382533
Start Date
May 30 2022
End Date
December 14 2022
Last Update
February 6 2023
Active Locations (1)
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1
Institute of Nutritional Sciences
Jena, Thuringia, Germany, 07743