Status:
TERMINATED
FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor)
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Indiana University
University of Alabama at Birmingham
Conditions:
Obesity
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Detailed Description
Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptat...
Eligibility Criteria
Inclusion
- Aged 18 to 50 years
- BMI ≥ 27 kg/m2
- Weight ≤ 350 lb
- Medical clearance from a primary care provider
- Willingness to follow a VLC weight-loss diet
- Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages
- No major food allergies or aversions
- Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only)
- Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase.
Exclusion
- Change in body weight ≥ 10% during prior 6 months
- Specialized diets (e.g., for medical or religious reasons)
- Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
- Current smoking (1 cigarette in the last week)
- Greater than moderate alcohol consumption (\> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
- Physician diagnosis of a major medical illness or eating disorder
- History of kidney stones
- Laboratory tests: ALT\>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes)
- Failed criminal offender background check or sex offender background check
- Use of recreational drugs
- Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder
- Exercise restrictions or at high risk for complications during exercise
- Female-specific exclusion criteria:
- Menopausal
- Any change in birth control medication during the 3 months prior to enrollment
- Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2020
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03394664
Start Date
May 9 2018
End Date
May 3 2020
Last Update
June 18 2021
Active Locations (1)
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1
Warren Conference Center and Inn
Ashland, Massachusetts, United States, 01721