Comparison of Two Different Diets on Health Outcomes
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|ClinicalTrials.gov Identifier: NCT00269646|
Recruitment Status : Unknown
Verified February 2009 by University of Virginia.
Recruitment status was: Active, not recruiting
First Posted : December 23, 2005
Last Update Posted : February 18, 2009
The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart disease, in persons with the metabolic syndrome.
Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber diet will not.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X||Behavioral: Low-carbohydrate and high-carbohydrate diets||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of a Low-Carbohydrate and High-Carbohydrate, High-Fiber Diet on Insulin Sensitivity and Risk Markers for Cardiovascular Disease in Men and Women With the Metabolic Syndrome|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||February 2008|
|Estimated Study Completion Date :||August 2009|
- Behavioral: Low-carbohydrate and high-carbohydrate diets
Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.
- insulin sensitivity [ Time Frame: before and after one month on each diet ]
- Total and LDL-cholesterol [ Time Frame: before and after one month on each diet ]
- C-reactive protein [ Time Frame: before and after one month on each diet ]
- Homocysteine [ Time Frame: before and after one month on each diet ]
- Fibrinogen [ Time Frame: before and after one month on each diet ]
- Cytokines IL-1, IL-2, IL-6 and TNF-alpha [ Time Frame: before and after one month on each diet ]
- Leukocyte adhesion molecules [ Time Frame: before and after one month on each diet ]
- Flow-mediated dilation [ Time Frame: before and after one month on each diet ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269646
|United States, Virginia|
|University of Virginia General Clinical Research Center|
|Charlottesville, Virginia, United States, 22904|
|Principal Investigator:||Glenn A Gaesser, PhD||University of Virginia|