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:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06660251
Eligibility Criteria:
Inclusion criteria for all subjects with and without MetS:
* Age = 18-75y
* Plasma creatinine value within the age-related reference range
* No history of acute or chronic diseases (e.g. diabetes or bowel disease)
* No use of vitamin or mineral supplements, no medication with antibiotics 2 months before recruitment and during the study
* Non-smoker
* Not consuming a special diet (vegetarian)
* No pregnancy, planned conception, or lactation
* No participation in another study.
Inclusion criteria for subjects without MetS:
* Normal BMI (18.6 to 29.0 kg / m 2 )
* Blood counts within reference ranges
* Normal ranges for liver enzymes (P-ALAT, P-AST, P-ALP), blood status, plasma triglycerides, plasma HDL cholesterol, plasma cholesterol, plasma glucose
Inclusion criteria for subjects with MetS:
A minimum of three of the following criteria according the National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III):
* Waist size \> 102 cm in men, \> 88 cm in women
* Fasting plasma glucose ≥ 5.6 mmol /l
* Triglycerides \> 1.7 mmol / l or treatment
* HDL 1.03 mmol / l in men, 1.29 mmol / l in women or treatment
* Blood pressure ≥ 130 / 85 mm Hg or medication. A value of B-HbA1c in the age-related reference range will be used to exclude diabetes.
Exclusion criteria for all research subjects :
* Smoker
* Pregnancy, planned conception, or lactation
* Medical treatment with antibiotics 2 months before recruitment and during the study
* Use of dietary supplements 2 weeks before and during the study
* Use of probiotics 2 months before and during the study
* Following a special diet (eg vegan, vegetarian, weight loss)
* Participation in another study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06660251
Study Brief:
Protocol Section:
NCT06660251