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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05898360
Eligibility Criteria:
Inclusion Criteria metsyn:
* BMI 30 to 43 kg/m2
* HOMA-IR index larger/same as 2.5
* And At least 3 out of 5 NCEP (National Cholesterol Education Program) metabolic syndrome criteria:
* Fasting plasma glucose ≥ 6.1 mmol/l,
* Triglycerides≥1.7mmol/l,
* Waist-circumference\>102cm,
* HDL-cholesterol\<1.04mmol/l,
* Bloodpressure≥130/85mmHg).
Inclusion healthy volunteers
* Body mass index (BMI) 18 to 25 kg/m2,
* Waist circumference between 79 cm and 94 cm and
* HOMA-IR index: ≤ 2.0 (measured as fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135)
Exclusion criteria; (all)
* Excessive weight loss of \>10% in the last months;
* Use of any medication, including proton pomp inhibitors and antibiotics in the past three months;
* Cholecystectomy;
* Untreated GI disease/abnormal bowel habits;
* Plasma aspartate aminotransferase and alanine aminotransferase are 2.5 times or more the upper limit of the normal range;
* A history of cardiovascular event (MI or pacemaker implantation);
* A history of heavy alcohol use (\>12 to 15 g of alcohol per day, or \>12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits);
* A dependency on alcohol or unable to pause the consumption of alcohol during the study period.
* An (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count \< 240);
* Unmotivated or not able to adhere to a specific diet;
* History of eating disorder;
* Night workers or people with deviant day/night rhythm;
* Pregnant, trying to get pregnant or breast feeding at inclusion;
* Irregular menstrual cycle;
* Hormonal replacement therapy (other than oral contraceptives).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05898360
Study Brief:
Protocol Section:
NCT05898360