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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:
Gateway Health Alliance
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE February 22, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date July 14, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
  • Bioavailability of a novel formulation of resveratrol (ResA) compared to a standard resveratrol supplement [ Time Frame: up to 1 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: 1 hour after consumption ]
    We will assess changes in vascular function measured by peripheral arterial tonometry.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
Official Title  ICMJE Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Dietary Supplement: ResA
    90mg of resveratrol conjugated with arginine.
  • Dietary Supplement: Resveratrol
    90mg of resveratrol.
  • Dietary Supplement: Placebo
    Made up of cellulose.
Study Arms  ICMJE
  • Experimental: Resveratrol
    The capsules will contain 90mg of resveratrol.
    Intervention: Dietary Supplement: 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.
    Intervention: Dietary Supplement: ResA
  • Placebo Comparator: Placebo
    The placebo will be cellulose.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
64
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
30
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564381
Other Study ID Numbers  ICMJE 270881
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Gateway Health Alliance
Investigators  ICMJE
Principal Investigator: Robert M Hackman, PhD University of California, Davis
PRS Account University of California, Davis
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP