Framingham State Food Study

Completed · Not applicable

Conditions studied: Obesity, Diabetes, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT02068885

Run by

Boston Children's Hospital

People needed

234

Starts

2014-08-17

Expected to finish

2017-05-01

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Abnormal HgA1c, TSH, BUN, creatinine; hematocrit < 30; ALT > 200% of 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

Where it is running

• Framingham State University — Framingham, Massachusetts, United States

Full record on ClinicalTrials.gov

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