We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An 18-month Trial of a Low Glycemic Load Diet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130299
First Posted: August 15, 2005
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Information provided by:
Boston Children’s Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130299


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Investigators
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
Study Director: Cara B Ebbeling, PhD Boston Children’s Hospital