Metabolic Fuels Study

Completed · Not applicable

Conditions studied: Obesity

In brief

This study will evaluate a potential physiologic mechanism underlying the effects of dietary composition on control of body weight

Key facts

Study ID

NCT02235038

Run by

Boston Children's Hospital

People needed

30

Starts

2014-10-01

Expected to finish

2017-05-01

Last updated by the study team

2017-07-21

Who can join

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

You may qualify if…

• Inclusion Criteria (as detailed in Framingham State Food Study, NCT02068885)
• Aged 18 to 65 years
• BMI ≥ 25 kg/m2
• BMI < 40 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
• 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:
• Willing to undergo additional procedures in this ancillary study

You may not qualify if…

• 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:
• Allergy or prior reaction to Lidocaine
• Medical condition or medication that would increase risk of bleeding, infection or skin reactions

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Framingham State University — Framingham, Massachusetts, United States

Full record on ClinicalTrials.gov

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