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:
Boston Children’s Hospital
ClinicalTrials.gov Identifier:
NCT00141076
First received: August 31, 2005
Last updated: August 27, 2010
Last verified: August 2010
  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

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

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   (Adult)
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
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, see Learn About Clinical Studies.

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
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: Diego Botero, MD Boston Children’s Hospital
  More Information

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 Boston Children’s Hospital:
obesity
glycemic index
insulin resistance
cardiovascular disease
diabetes

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

ClinicalTrials.gov processed this record on August 25, 2016