Glycemic Index and CVD: a Crossover Feeding Study - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Charles H. Hood Foundation
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00141076

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

MedlinePlus related topics: Obesity

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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
Estimated 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

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

Study ID Numbers:	59240-#2, 2002-P-001495/22 (BWH)
Study First Received:	August 31, 2005
Last Updated:	December 13, 2006
ClinicalTrials.gov Identifier:	NCT00141076
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

obesity
glycemic index
insulin resistance
cardiovascular disease
diabetes

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Overweight
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 13, 2009