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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Charles H. Hood Foundation |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00130299 |
The primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial.
Condition | Intervention |
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Obesity |
Behavioral: low glycemic load diet Behavioral: low fat diet |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An 18-Month Randomized Controlled Trial of a Low Glycemic Load Diet |
Study Start Date: | July 2004 |
Study Completion Date: | December 2006 |
The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s. Effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to combat type 2 diabetes and heart disease. Evidence from animal studies, short-term human studies and epidemiology suggests that diets designed to minimize the rise in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of obesity and related complications. This project proposes an month RCT comparing a low glycemic load diet to a conventional low fat diet. Both diet groups will receive identical treatment intensity, behavioral modification and physical activity recommendations. The primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes include insulin resistance and CVD risk factors. Compliance will be assessed by interviewer-administered, 24-hour dietary recalls.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David S Ludwig, MD, PhD | Children's Hospital Boston |
Study Director: | Cara B Ebbeling, PhD | Children's Hospital Boston |
Study ID Numbers: | 59240-#1 |
Study First Received: | August 12, 2005 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00130299 |
Health Authority: | United States: Federal Government |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |