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Glycemic Index and CVD: a Crossover Feeding Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141076
First Posted: September 1, 2005
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Information provided by:
Boston Children’s Hospital
  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
Intervention Model: Crossover Assignment
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
2002-P-001495/22 (BWH)
First Submitted: August 31, 2005
First Posted: September 1, 2005
Last Update Posted: August 30, 2010
Last Verified: August 2010

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