An 18-month Trial of a Low Glycemic Load Diet

This study has been completed.
Sponsor:
Collaborators:
Charles H. Hood Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00130299
First received: August 12, 2005
Last updated: August 27, 2010
Last verified: August 2010

August 12, 2005
August 27, 2010
July 2004
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change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).
change in adiposity as measured by DEXA.
Complete list of historical versions of study NCT00130299 on ClinicalTrials.gov Archive Site
change in insulin resistance as measured by the homeostasis model assessment; change in glucose tolerance as measured by an oral glucose tolerance test (OGTT); change in cardiovascular disease risk factors
change in insulin resistance as measured by the homeostasis model assessment; change in glucose tolerance as measured by an OGTT; change in cardiovascular disease risk factors
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An 18-month Trial of a Low Glycemic Load Diet
An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Behavioral: low glycemic load diet
  • Behavioral: low fat diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
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Inclusion Criteria:

  • Age 18 to 35 years
  • Body mass index (BMI) ≥ 30 kg/m2
  • Access to a working telephone
  • Conversant in English
  • Written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition

Exclusion Criteria:

  • Body weight >300 lbs
  • Major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem
  • An obesity-associated genetic syndrome (e.g., Prader-Willi)
  • An abnormal screening laboratory test (ALT, creatinine, BUN, hematocrit)
  • Fasting blood glucose ≥ 126 mg/dl)
  • Taking any prescription medication that affects body weight (glucocorticoids, neuropsychiatric agents), blood pressure, or serum cholesterol concentrations
  • Currently smoking (1 cigarette during any of the last 7 days)
  • Previous diagnosis of an eating disorder (anorexia nervosa, bulimia, binge-eating disorder)
  • If female, not pregnant or planning to become pregnant in the next 18 months and not lactating
  • Failure to complete the pre-enrollment visits
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130299
59240-#1, R01DK059240
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Not Provided
Children's Hospital Boston
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Charles H. Hood Foundation
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Cara B Ebbeling, PhD Children's Hospital Boston
Children's Hospital Boston
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP