Glycemic Index and CVD: a Crossover Feeding Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141076

Enrollment

Registered

2005-09-01

Start date

2003-10-31

Completion date

2006-07-31

Last updated

2010-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, glycemic index, insulin resistance, cardiovascular disease, diabetes

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.

Interventions

BEHAVIORALlow vs high glycemic index diet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity as measured by FS-IVGTT	—

Secondary

Measure	Time frame
CVD risk factors	—
Postprandial studies of oxidative stress	—
Thermic effect of food	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026