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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators hope to learn if resveratrol supplementation can be beneficial for the cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are interested in learning if a novel form of resveratrol, ResA, which is a mixture of resveratrol with amino acid, may have greater bioavailability and lead to greater improvement in vascular function, compared to standard resveratrol supplement.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: ResA Dietary Supplement: Resveratrol Dietary Supplement: Placebo Phase 1 Phase 2

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
Study Start Date : March 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Resveratrol
The capsules will contain 90mg of resveratrol.
Dietary Supplement: Resveratrol
90mg of resveratrol.
Experimental: ResA
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 to 70 years of age
  • Lack of menses in the last year and FSH 23-116.3 mlU/mL
  • Subject is willing and able to comply with the study protocols.
  • Subject is willing to consume resveratrol supplements/placebo capsules on three separate occasions.
  • BMI 18.5-34.9 kg/m2
  • Weight ≥ 110 pounds
  • LDL-C ≥ 130 mg/dL

Exclusion Criteria:

  • BMI ≥ 35 kg/m2
  • Self reported use of anticoagulation agents including NSAIDs
  • Self reported use of oral cortisone or other immunosuppressive agents,
  • Self reported underlying neoplasia or immunological disease
  • Food faddists or those taking a non-traditional diet
  • Self reported physical activity restricted or reduced due to chronic health conditions
  • Self reported diabetes
  • Blood pressure ≥ 140/90 mm Hg
  • PFA-100 readings 10 % outside of normal reference range (normal reference range for ADP-Collagen: 71-118 sec; Epinephrine-Collagen: 94-193 sec).
  • Self reported renal or liver disease
  • Self reported heart disease, which includes cardiovascular events and stroke
  • Self reported Cushing's syndrome
  • Self reported chronic/routine high intensity exercise
  • Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
  • Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant.
  • Self reported cancer within past 5 years
  • Self reported history of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
  • Self reported use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil), tranylcypromine (Parnate), etc)
  • Self reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food,
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
University of California, Davis - Ragle Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Gateway Health Alliance
Investigators
Principal Investigator: Robert M Hackman, PhD University of California, Davis
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01564381     History of Changes
Other Study ID Numbers: 270881
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by University of California, Davis:
Cardiovascular disease

Additional relevant MeSH terms:
Resveratrol
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents