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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT02300857
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 55 years
* BMI ≥ 23 kg/m2
* BMI \< 45 kg/m2 and weight ≤ 300 lbs (136 kg)
* Medical clearance from a primary care provider
* Student or employee at Framingham State University throughout enrollment in the study
* Community-based participants from the greater Framingham and Assabet Valley communities
* Willing and able to eat and drink only the foods and beverages on the study menus
* Willing to eat in the dining hall
* Willing to abstain from consuming alcohol during participation
Additional Inclusion Criteria:
* Body circumference of \<64 in
* Willingness to undergo 2, 30-minute MRI scans
Exclusion Criteria (as detailed in Framingham State Food Study, NCT02068885):
* Change in body weight exceeding ±10% during prior year
* Recent adherence to a special diet
* Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
* Chronic use of any medication or dietary supplement that could affect study outcomes
* Current smoking (1 cigarette in the last week)
* Heavy baseline alcohol consumption or history of binge drinking
* Physician diagnosis of a major medical/psychiatric illness or eating disorder
* Abnormal blood glucose, TSH, CBC, BUN, Creatinine
* ALT greater than 150% of the normal upper limit
* Plans for a vacation during the study that would preclude adherence to prescribed diet
* Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
Additional Exclusion Criteria:
* Previous bariatric surgery
* Other contraindications to MRI scanning (severe claustrophobia/extensive orthopedic hardware/pacemaker, cerebral aneurysm clip)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02300857
Study Brief:
Protocol Section:
NCT02300857