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
  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:


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
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
Children's Hospital Boston
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 August 27, 2014