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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT04255368
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women of any race or ethnicity
* Age 21-50 y
* BMI 20-24.9 kg/m2 or BMI 30-39.9 kg/m2
Exclusion Criteria:
* Age \> 50 y
* BMI outside of the normal-weight or obese range (BMI \< 20 kg/m2; BMI 25-29.9 kg/m2; or BMI \> or = 40 kg/m2)
* Pregnant or planning to become pregnant during the course of the study; currently breastfeeding (females)
* Vegetarians
* Smokers or recreational drug users
* Individuals with gastrointestinal diseases or complaints, chronic illnesses or other metabolic diseases (including trimethylaminuria)
* Individuals who have taken antibiotics within the past 2 months
* Individuals who are not willing to discontinue pre- and probiotics and dietary supplements for the time leading up to 2 months before the study and during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT04255368
Study Brief:
Protocol Section:
NCT04255368