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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02452567
Eligibility Criteria:
Inclusion Criteria:
* BMI 21.0-24.9 kg/m²
* Weight stable (+/- 2% for at least 3 months before enrollment)
* Two or more of the following: IHTG content ≥5.6%, HOMA- IR index ≥ 2.5, HbA1C ≥ 5.7%, 2-hr OGTT plasma glucose concentration ≥ 140 mg/dl, fasting plasma glucose concentration ≥ 100 mg/dl.
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Evidence of significant organ system dysfunction or disease (e.g., diabetes, chronic kidney disease, advanced heart disease, etc.)
* Men who consume \>21 units (e.g., glass of wine or bottle of beer) of alcohol per week and women who consume \>14 units of alcohol per week
* Use of dietary supplements or medications known to affect metabolism
* Eating disorder (assessed by using the Eating Disorder Examination Questionnaire \[EDE-Q\])
* Participation in structured endurance or resistance exercise program \>150 min/week
* Use of tobacco products
* Unable or unwilling to follow the study protocol or the research team believes that for any reason the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous appointments/contact arrangements
* Individuals that take Coumadin or similar anticoagulants
* Use of antibiotics in last 60 days
* Previous bariatric surgery
* Cancer or cancer that has been in remission for \<5 years
* Major psychiatric illness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02452567
Study Brief:
Protocol Section:
NCT02452567