Framingham State Food Study (NCT02068885) | Clinical Trial Compass
CompletedNot Applicable
Framingham State Food Study
United States234 participantsStarted 2014-08-17
Plain-language summary
This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 to 65 years
* BMI ≥ 25 kg/m2
* Weight ≤ 425 lbs
* Medical clearance from a primary care provider
* Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study
* Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects)
* Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions
* Willingness to eat in the dining hall
* Willingness to abstain from consuming alcohol during participation
Exclusion Criteria:
* 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 (\> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months)
* Physician diagnosis of a major medical/psychiatric illness or eating disorder
* Abnor…
What they're measuring
1
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Timeframe: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance