Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05382533
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT05382533
Study Brief:
Protocol Section:
NCT05382533