An 18-month Trial of a Low Glycemic Load Diet

NCT00130299 | Completed

• 2 other identifiers: 59240-#1R01DK059240
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

low glycemic load diet BEHAVIORAL

low fat diet BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Charles H. Hood Foundation: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Ebbeling CB, Leidig MM, Sinclair KB, Seger-Shippee LG, Feldman HA, Ludwig DS. Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults. Am J Clin Nutr. 2005 May;81(5):976-82. doi: 10.1093/ajcn/81.5.976.

  PMID: 15883418 BACKGROUND

• Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.

  PMID: 17507345 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: July 1, 2004
• Study Completion: December 1, 2006
• Last Updated: August 30, 2010

Record last verified: 2010-08

Locations

US (1)