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CompletedNCT00141076Updated Aug 30, 2010

Glycemic Index and CVD: a Crossover Feeding Study

An interventional study of low vs high glycemic index diet in Obesity, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-30.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • obesity
  • glycemic index
  • insulin resistance
  • cardiovascular disease
  • diabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 24 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
24 participants

Interventions

  • Behaviorallow vs high glycemic index diet
06

What researchers measure

Primary outcomes

  1. Insulin sensitivity as measured by FS-IVGTT

Secondary outcomes

  1. CVD risk factors

  2. Postprandial studies of oxidative stress

  3. Thermic effect of food

07

Study locations

1 site
  • Brigham & Women's Hospital
    Boston, Massachusetts, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00141076
Lead sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Charles H. Hood Foundation
First posted
Sep 1, 2005
Start date
Oct 2003
Completion
Jul 2006
Last update
Aug 30, 2010

Study contacts

David S Ludwig, MD, PhD
principal investigator · Boston Children's Hospital
Diego Botero, MD
study director · Boston Children's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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