Glycemic Index and CVD: a Crossover Feeding Study

Obesity Clinical Trial

Official title:

Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141076
• Other study ID #: 59240-#2
• Secondary ID: R01DK0592402002-
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: August 27, 2010
• Start date: October 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2010
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Behavioral:
• low vs high glycemic index diet

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Boston	Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity as measured by FS-IVGTT
Secondary	CVD risk factors
Secondary	Postprandial studies of oxidative stress
Secondary	Thermic effect of food