NCT01564381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

February 22, 2012

Last Update Submit

July 13, 2017

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

  • Bioavailability of a novel formulation of resveratrol (ResA) compared to a standard resveratrol supplement

    We will assess metabolites concentrations of resveratrol and ResA in plasma via HPLC method.

    up to 2 hour after consumption

  • Change in vascular function in response to ResA compared to native resveratrol

    We will assess changes in vascular function measured by peripheral arterial tonometry.

    up to 2 hours after consumption

Secondary Outcomes (1)

  • Change in platelet reactivity in response to ResA intake

    1 hour after consumption

Study Arms (3)

Resveratrol

EXPERIMENTAL

The capsules will contain 90mg of resveratrol.

Dietary Supplement: Resveratrol

ResA

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

The placebo will be cellulose.

Dietary Supplement: Placebo

Interventions

ResADIETARY_SUPPLEMENT

90mg of resveratrol conjugated with arginine.

ResA
ResveratrolDIETARY_SUPPLEMENT

90mg of resveratrol.

Resveratrol
PlaceboDIETARY_SUPPLEMENT

Made up of cellulose.

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis - Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Robert M Hackman, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 27, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

US(1)