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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03005951
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males
2. No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder.
3. Normal or corrected vision using the Snellen chart
4. Normal hearing
5. BMI greater than or equal to 95th percentile according to the Center for Disease Control and Prevention (CDC) growth charts
6. HbA1C less than or equal to 5.6%
7. Hemoglobin level of greater or equal to 12g/dL
Exclusion Criteria:
1. History of chronic illness and chronic use of medications that affect cognitive or glucose metabolism
2. History of substance, nicotine or alcohol dependence as assessed by CRAFFT (CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE) questionnaire
3. History of eating disorder as assessed by the SCOFF questionnaire.
4. Developmental delay
5. Hearing and vision problems as assessed by the Snellen chart
6. Previous history of bariatric surgery
7. Currently taking supplements or medications indicated for weight loss
8. Previous history of head injury associated with loss of consciousness for several minutes
9. History of Epilepsy
10. Allergy to any of the foods used for the test breakfasts
The inclusion and exclusion criteria for lean subjects will be identical to that of obese subjects with the exception that the lean subjects will be less than or equal to the 85th percentile for BMI, according to CDC growth charts.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT03005951
Study Brief:
Protocol Section:
NCT03005951