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Glycemic Index and CVD: a Crossover Feeding Study

Not Applicable
Completed
Conditions
Obesity
Registration Number
NCT00141076
Lead Sponsor
Boston Children's Hospital
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Insulin sensitivity as measured by FS-IVGTT
Secondary Outcome Measures
NameTimeMethod
CVD risk factors
Postprandial studies of oxidative stress
Thermic effect of food

Trial Locations

Locations (1)

Brigham & Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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