Status:
COMPLETED
Popular Diets Study
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease r...
Detailed Description
For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD). Over the last few yea...
Eligibility Criteria
Inclusion
- BMI ≥ 27 kg/m2
- Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals
- Available for scheduled hospital admissions
- Willing to abstain from alcohol consumption for the duration of the study
- If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)
Exclusion
- Weight \> 350 lbs
- Change in body weight (± 10%) over preceding year
- Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- Smoking (1 cigarette in the last week)
- High levels of physical activity
- Currently following a special diet
- Abnormal laboratory screening tests
- Type 2 diabetes mellitus
- Allergies or aversions to foods on the study menu
- Previous diagnosis of an eating disorder or any other mental health disorder
- If female, pregnant in the past 12 months or planning to become pregnant during the study period
- If female, lactating in the preceding 12 months
- If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00315354
Start Date
April 1 2006
End Date
April 1 2013
Last Update
November 23 2016
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115