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 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT01705093
Eligibility Criteria:
Inclusion Criteria:
* Male subjects, age 14 - 18 years.
* BMI for age and gender \>75th percentile (based on CDC growth charts)
* Subject is willing and able to comply with the study protocols.
Exclusion Criteria:
* Inability to wear PAT probes
* Inability to remain still and remain quiet during test procedures
* BMI for age and gender ≤ 75th percentile (based on CDC growth charts)
* The use of medications that affect vascular function
* Regular use of dietary supplements during the last 6 months
* Blood pressure for age, gender and height ≥95th percentile
* Chronic/routine high intensity exercise or current participation in a sports program
* Self/Parent reported use of anticoagulation agents including NSAIDs
* Self/Parent reported use of oral cortisone or other immunosuppressive agents,
* Self/Parent reported underlying neoplasia or immunological disease
* Self/Parent reported diabetes
* Food faddists or those taking a non-traditional diet
* Allergies to fruit
* Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference
* range) if determined to be clinically significant by the study physician.
* Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
* Asthma (can be worsened by mild to moderate food allergies).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT01705093
Study Brief:
Protocol Section:
NCT01705093