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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02346994
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
* Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
Exclusion Criteria:
* Any endocrine disorder, including type 1 diabetes
* Weight loss attempted in past 3 months
* Currently using medication (prescription or over-the-counter) that could impact study outcomes
* Asthma
* Anemia
* Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
* Use of (current or in the past 4 weeks) any investigational medications or devices
* Allergy/sensitivity to wheat, milk, eggs, nuts
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
18 Years
Study:
NCT02346994
Study Brief:
Protocol Section:
NCT02346994