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	Behavior: low vs high glycemic index diet

Further Study Details: 

Primary Outcomes: Insulin sensitivity as measured by FS-IVGTT
Secondary Outcomes: CVD risk factors; Postprandial studies of oxidative stress; Thermic effect of food
Expected Total Enrollment:  24

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   -   35 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00141076

Beth Monroe      617 355-6097 

Massachusetts
      Brigham & Women''''s Hospital, Boston,  Massachusetts,  United States; Recruiting

Study chairs or principal investigators

David S Ludwig, MD, PhD,  Principal Investigator,  Children''''s Hospital Boston   
Diego Botero, MD,  Study Director,  Children''''s Hospital Boston   

Study ID Numbers:  59240-#2; 2002-P-001495/22 (BWH)
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00141076
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06