Status:
COMPLETED
Metabolic Fuels Study
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Framingham State University
Brigham and Women's Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will evaluate a potential physiologic mechanism underlying the effects of dietary composition on control of body weight
Detailed Description
The challenge in maintaining long-term weight loss is well known, however new research suggests diet quality may be the driving factor. A pilot study from our group demonstrated that a higher carbohyd...
Eligibility Criteria
Inclusion
- 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
- • Willing to undergo additional procedures in this ancillary study
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02235038
Start Date
October 1 2014
End Date
May 1 2017
Last Update
July 21 2017
Active Locations (4)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Framingham State University
Framingham, Massachusetts, United States, 01702