Glycemic Index and CVD: a Crossover Feeding Study

NCT ID: NCT00141076

Last Updated: 2010-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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low vs high glycemic index diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Charles H. Hood Foundation

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Principal Investigators

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David S Ludwig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Diego Botero, MD

Role: STUDY_DIRECTOR

Boston Children's Hospital

Locations

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Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK059240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2002-P-001495/22 (BWH)

Identifier Type: -

Identifier Source: secondary_id

59240-#2

Identifier Type: -

Identifier Source: org_study_id

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