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An 18-month Trial of a Low Glycemic Load Diet

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.
 
ClinicalTrials.gov Identifier: NCT00130299
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : August 30, 2010
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Information provided by:
Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE August 12, 2005
First Posted Date  ICMJE August 15, 2005
Last Update Posted Date August 30, 2010
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2005)
change in adiposity as measured by DEXA.
Change History Complete list of historical versions of study NCT00130299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An 18-month Trial of a Low Glycemic Load Diet
Official Title  ICMJE An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: low glycemic load diet
  • Behavioral: low fat diet
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00130299
Other Study ID Numbers  ICMJE 59240-#1
R01DK059240 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Charles H. Hood Foundation
Investigators  ICMJE
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
Study Director: Cara B Ebbeling, PhD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date August 2010

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