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Glycemic Index and CVD: a Crossover Feeding Study

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00141076
First received: August 31, 2005
Last updated: August 27, 2010
Last verified: August 2010
History of Changes
  Purpose

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.


Condition Intervention
Obesity
 Behavioral: low vs high glycemic index diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Insulin sensitivity as measured by FS-IVGTT

Secondary Outcome Measures:
  • CVD risk factors
  • Postprandial studies of oxidative stress
  • Thermic effect of food

Estimated Enrollment: 24
Study Start Date: October 2003
Study Completion Date: July 2006
Detailed Description:

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese male adults in a 10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic effect of food.

  Eligibility

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

Inclusion Criteria:

  • age 18 to 35 years
  • male
  • BMI ≥ 27 ≤45 kg/m2
  • willingness to refrain from alcohol and caffeinated beverage consumption for duration of study

Exclusion Criteria:

  • major medical illness
  • an abnormal screening laboratory test
  • taking any prescription medications that might affect body weight
  • current smoking (1 cigarette during any of the last 7 days)
  • consuming special diets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141076

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Children's Hospital Boston
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Investigators
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Diego Botero, MD Children's Hospital Boston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141076     History of Changes
Other Study ID Numbers: 59240-#2, R01DK059240, 2002-P-001495/22 (BWH)
Study First Received: August 31, 2005
Last Updated: August 27, 2010
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
obesity
glycemic index
insulin resistance
cardiovascular disease
diabetes

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013