Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT01564381|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Dietary Supplement: ResA Dietary Supplement: Resveratrol Dietary Supplement: Placebo||Phase 1 Phase 2|
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. To reduce the risk of cardiovascular disease (CVD) and its associated health care costs, nutrition and health recommendations strongly advocate the consumption of a diet rich in fruits and vegetables. In addition to essential vitamins and minerals, fruits and vegetables contain a number of bioactive compounds that may be involved in vascular function.
The "French Paradox" refers to diet patterns that, despite being high in saturated fat, are associated with a relatively low cardiovascular risk. An important aspect of many of the diets that were identified in the French Paradox studies is a significant intake of wine, particularly red wine, which can contain an array of phytochemicals that have been postulated to improve cardiovascular health. A polyphenolic that has received particular attention is this regard is resveratrol.
The stilbene resveratrol is found predominately in red grapes, red wine, peanuts and some berries, and it has been touted in the popular press for its potential health-promoting benefits. Emerging evidence suggests a role for resveratrol in the protection against numerous degenerative health problems including CVD and certain cancers, diabetes and some forms of neurodegeneration.
The amount of resveratrol in most foods is very low; thus obtaining the amounts of this compound that have been associated with improved health in animal models is difficult for humans. ResA is a product produced using patented technology that physically binds resveratrol to arginine, creating a novel conjugate. In the preliminary studies the ResA conjugate produced higher peak plasma levels, as well as total plasma levels that persist for a longer period of time when fed to rats. Whether similar results would occur in humans, and the extent to which increasing blood resveratrol concentration can be associated with positive cardiovascular effects in an at-risk population is the subject of this project.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
The capsules will contain 90mg of resveratrol.
Dietary Supplement: Resveratrol
90mg of resveratrol.
ResA is a product produced by using patented technology that physically binds resveratrol to arginine, creating a novel conjugate. The capsules will contain 90mg of resveratrol.
Dietary Supplement: ResA
90mg of resveratrol conjugated with arginine.
Placebo Comparator: Placebo
The placebo will be cellulose.
Dietary Supplement: Placebo
Made up of cellulose.
- Bioavailability of a novel formulation of resveratrol (ResA) compared to a standard resveratrol supplement [ Time Frame: up to 2 hour after consumption ]We will assess metabolites concentrations of resveratrol and ResA in plasma via HPLC method.
- Change in vascular function in response to ResA compared to native resveratrol [ Time Frame: up to 2 hours after consumption ]We will assess changes in vascular function measured by peripheral arterial tonometry.
- Change in platelet reactivity in response to ResA intake [ Time Frame: 1 hour after consumption ]We will assess platelet function in response to ADP, collagen and arachidonic acid as measured by platelet aggregometer.
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): NCT01564381
|United States, California|
|University of California, Davis - Ragle Human Nutrition Research Center|
|Davis, California, United States, 95616|
|Principal Investigator:||Robert M Hackman, PhD||University of California, Davis|