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
  Purpose

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
Obesity
Behavioral: low glycemic load diet
Behavioral: low fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).

Secondary Outcome Measures:
  • 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

Study Start Date: July 2004
Study Completion Date: December 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130299

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Charles H. Hood Foundation
Investigators
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Cara B Ebbeling, PhD Children's Hospital Boston
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00130299     History of Changes
Other Study ID Numbers: 59240-#1, R01DK059240
Study First Received: August 12, 2005
Last Updated: August 27, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014