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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT05104502
Eligibility Criteria:
Inclusion Criteria:
* Age: 20-40 years, to constitute a young study population
* Gender: male subjects, to control for gender differences
* BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
* Weight: 120 lbs or more
* Fasting glucose: 70-100 mg/dL, to ensure that fasting can be tolerated without inducing dangerously low levels of blood glucose
* Subjects must be willing to undergo a period of 36 hours of water-only fasting
* Subjects must be willing to collect samples of each bowel movement produced throughout the entire study period for microbiome analysis
* Subjects must be willing to collect blood pricks for blood glucose levels using a Contour Next One Blood Glucose Testing Kit during the fasting stage of the study protocol.
Exclusion Criteria:
* Current smoking
* Anemia
* Pregnancy or current breastfeeding
* Chronic diseases including diabetes mellitus, thyroid disease, metabolic syndrome, cancer, or previous cardiovascular events
* Gastrointestinal diseases including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease
* Consumption of \>1 alcoholic drink/day
* Extreme dietary or exercise patterns
* Recent weight fluctuations (greater than 10% in the last six months)
* Regular use of over-the-counter allergy or pain medications (\>1/week)
* Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones
* Use of hormonal birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT05104502
Study Brief:
Protocol Section:
NCT05104502