Cardiovascular DiseasePhase 1/2NCT01564381
Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
A Phase 1/2 study testing ResA and Resveratrol in people with Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- ResA and Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis - Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- ResA, Resveratrol, Placebo
- Keywords
- Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResADietary supplement
90mg of resveratrol conjugated with arginine.
ResveratrolDietary supplement
90mg of resveratrol.
PlaceboDietary supplement
Made up of cellulose.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | The capsules will contain 90mg of resveratrol. Receives: 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. Receives: Dietary Supplement: ResA |
| Placebo | Placebo comparator | The placebo will be cellulose. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 2 hours after consumption
Secondary outcomes (1)
Change in platelet reactivity in response to ResA intake
We will assess platelet function in response to ADP, collagen and arachidonic acid as measured by platelet aggregometer.
Measured: 1 hour after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway Health Alliance
- Responsible party
- Sponsor
- Investigators
- Robert M Hackman, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564381
- Sponsor's protocol ID
- 270881
- Status last verified
- Jul 2017
- First submitted
- 22 Feb 2012
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01564381
- Acronym / sponsor ID
- 270881
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Gateway Health Alliance
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolThe capsules will contain 90mg of resveratrol. |
| ResA | Experimental | Dietary Supplement: ResAResA 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo will be cellulose. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResA90mg of resveratrol conjugated with arginine. | Dietary supplement | ResA |
| Resveratrol90mg of resveratrol. | Dietary supplement | Resveratrol |
| PlaceboMade up of cellulose. | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Change in platelet reactivity in response to ResA intake
Time frame: 1 hour after consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Hackman, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ResA and Resveratrol in people with Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of a novel formulation of resveratrol (ResA) compared to a standard resveratrol supplement (time frame: up to 2 hour after consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.