Glycemic Index and CVD: a Crossover Feeding Study

This study has been completed.
Sponsor:
Collaborators:
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

August 31, 2005
August 27, 2010
October 2003
Not Provided
Insulin sensitivity as measured by FS-IVGTT
Same as current
Complete list of historical versions of study NCT00141076 on ClinicalTrials.gov Archive Site
  • CVD risk factors
  • Postprandial studies of oxidative stress
  • Thermic effect of food
Same as current
Not Provided
Not Provided
 
Glycemic Index and CVD: a Crossover Feeding Study
Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
Obesity
Behavioral: low vs high glycemic index diet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2006
Not Provided

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
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141076
59240-#2, R01DK059240, 2002-P-001495/22 (BWH)
Not Provided
Not Provided
Children's Hospital Boston
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Charles H. Hood Foundation
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Diego Botero, MD Children's Hospital Boston
Children's Hospital Boston
August 2010

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