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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05417360
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 28 kg/m2 \< 40 kg/m2
* Weight stable for at least 3 months (± 2 kg).
Exclusion Criteria:
* Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
* Gastroenterological diseases
* Surgery on the gastrointestinal tract (ex.Bariatric surgery)
* Cardiovascular diseases, cancer, liver or kidney malfunction, a disease with a life expectancy of \< 5 years;
* Alcohol (\>15 standard drinks per week) or drug abuse
* Excessive nicotine use is defined as \>20 cigarettes per day;
* Use of prebiotics or probiotics 3 months prior to the start of the study;
* Intensive exercise training, \> 3 hours a week;
* Use of any medication influencing glucose or fat metabolism (ex. lipid-lowering-drugs e.g. PPAR γ (peroxisome proliferator-activated receptors) or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide, and insulin), inflammation (e.g. anti-inflammatory or immunosuppressive drugs) and anti-oxidants);
* Regular use of laxatives
* Use of antibiotics in the last 3 months
* Vegan
* Lactose intolerance
* Pregnancy or lactation
* Concomitant participation in another study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT05417360
Study Brief:
Protocol Section:
NCT05417360