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Glycemic Index and CVD: a Crossover Feeding Study

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Boston Children's Hospital

Status

Completed

Conditions

Obesity

Treatments

Behavioral: low vs high glycemic index diet

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00141076
2002-P-001495/22 (BWH)
R01DK059240 (U.S. NIH Grant/Contract)
59240-#2

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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