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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Charles H. Hood Foundation |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00141076 |
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 |
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Obesity |
Behavioral: low vs high glycemic index diet |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | July 2006 |
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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
age 18 to 35 years
Exclusion Criteria:
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States |
Principal Investigator: | David S Ludwig, MD, PhD | Children's Hospital Boston |
Study Director: | Diego Botero, MD | Children's Hospital Boston |
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 |
obesity glycemic index insulin resistance cardiovascular disease diabetes |
Obesity Metabolic Diseases Diabetes Mellitus Overweight Insulin Body Weight Hyperinsulinism |
Signs and Symptoms Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic disorder |