Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2006-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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1
Low glycemic index diet
Low glycemic index diet
Feeding protocol, all foods prepared in a metabolic kitchen
2
Low fat diet
Low fat diet
Feeding protocol, all foods prepared in a metabolic kitchen
3
Very low carbohydrate diet
Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen
Interventions
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Low glycemic index diet
Feeding protocol, all foods prepared in a metabolic kitchen
Low fat diet
Feeding protocol, all foods prepared in a metabolic kitchen
Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Brigham and Women's Hospital
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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David S. Ludwig, MD, PhD
Professor
Principal Investigators
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David S Ludwig, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Cara B Ebbeling, PhD
Role: STUDY_DIRECTOR
Boston Children's Hospital
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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References
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