Vascular ResistancePhase 1/2NCT01842399
Resveratrol and Cardiovascular Health in the Elderly
A Phase 1/2 study testing Resveratrol in people with Vascular Resistance and Hypertension, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it can have positive effects on human health. Lab studies show that it may help lower blood sugar, improve heart and blood vessel health, and prevent cancer. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Resistance, Hypertension
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2015to 21 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female, age 50 years or older
- BMI greater than or equal to 25 or less than or equal to 35 and weight less than 300 pounds.
- Participants must provide their own consent.
- Females must be menopausal or have had a bilateral oophorectomy.
- If over 55 years old: no menses for 12 months or longer. Women over 55 years old who haven't had a period for a year will be considered menopausal and do not need a FSH test.
- If 50-55 years old: no menses for 12 months AND an FSH level greater than or equal to 20. Women between 50 and 55 years old who haven't had a period for a year, will need FSH test. If their FSH test is more than 20, they will be considered menopausal. If their FSH test is less than 20, they will not be eligible to participate.
Who cannot join
- Liver Function Tests (LFT) greater than 2 times normal.
- Abnormal thyroid function, as evidenced by Free T3, t4, Free T4 or TSH +/- 5% of the lab reference ranges
- History of diabetes (gestational diabetes ok).
- Hemoglobin A1C greater than 6.5 and/or fasating serum glucose greater than or equal to 126 mg/dL.
- Renal dysfunction (GFR less than 60 mL/min).
- Abnormal Coagulation profile (PT/PTT and INR).
Show all 34Show fewer
- Medications: (Due to potential interaction with resveratrol)
- Cholesterol medications Atorvastatin(Lipitor) Rosuvastatin (Crestor), Simvastatin (Zocor), Gemfibrazole (Lopid), Niacin (Niacor), etc.
- Aspirin greater than 81 mg
- Taking medicines that may increase the risk of bleeding such as Coumadin (warfarin), Plavix (clopidogrel), Xarelto (rivaroxaban), Pradaxa (dabgatran), Eliquis (apixaban) or Heparin (blood thinning medications) due to their potential interaction with resveratrol and the increased risk for bleeding with the muscle biopsy.
- Taking supplements such as Ginkgo biloba, Ginseng or Ginger due to their increased risk of bleeding with the muscle biopsy.
- Chronic (daily) use of non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen)-due to potential interaction with resveratrol. (Occasional use is ok if the participant does not take them 4 days before and 3 days after the muscle biopsy procedure).
- Anti-diabetic medications: Insulin, Metformin (Glucophage, Avandamet, Glibomet, etc), Rosiglitazone (Avandia), Exenatide (Byetta), Sitagliptin (Januvia), etc
- Testosterone and estrogen supplement
- Current glucocorticoid use, or up to 3 months ago (nasal, topical, ophthalmic, and inhaled use are not exclusionary)
- Vitamin supplements containing resveratrol
- Contraindications to MRI Study; e.g. metal implants, pacemakers, etc and hip replacements (metal or plastic) due to inhibiting visualization of the area being scanned.
- Smoking nicotine presently or within the last 3 months.
- Known congestive heart failure now or in the past.
- Alcohol consumption more than 30 grams (equivalent to about 10 ounces of wine; 24 ounces of beer; 3 ounces of hard liquor) for men or 15 grams for women (equivalent to about 5 ounces of wine; 12 ounces of beer; 1.5 ounces of hard liquor) daily.
- Positive screening result for alcohol use at the screening visit. Score 8+ on the AUDIT.
- Positive HIV, Hepatitis B or C testing.
- Positive urine drug test (exclusionary due to unknown interaction affect with study medication and question of compliance with study procedures).
- Benzodiazepines
- Amphetamines
- Barbiturates
- Cannabis
- Cocaine
- Receipt of any investigational products (e.g. drugs, supplements, dietary interventions) as part of a research study within 30 days of initial dose administration
- Unable to comply with the study requirements and procedures.
- Unable to perform treadmill testing due to reasons such as orthopedic problems, moderate to severe aortic stenosis as found on echocardiogram at ScreeningVisit, history of myocardial infarction in the last three months or angina (under treatment).
- Unable to perform knee strength testing due to reasons such as bilateral knee replacements.
- Unable to perform hand grip testing due to any limitation such as pain or deformity.
- Allergy or intolerance to local anesthetic- Lidocaine.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial
Background:
- Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it can have positive effects on human health. Lab studies show that it may help lower blood sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test different dose levels of Resveratrol to see what kind of effects it has on older overweight people. It will be tested in healthy volunteers at least 50 years of age.
Read more
Objectives:
- To test the effects of different dose levels of Resveratrol on heart and blood vessel health.
Eligibility:
- Healthy overweight nonsmoking volunteers at least 50 years of age.
Design:
- This study will involve a screening visit and four study visits. Some of the study visits will involve overnight inpatient stays.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will be given a list of foods that they should avoid eating while on the study.
- Participants will be separated into three groups. Two groups will take different dose levels of the study drug. The third group will take a placebo.
- At the first study visit, participants will stay in the clinical center overnight for 2 days of tests. They will provide blood and urine samples and have body scans to measure fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be performed. At this visit, they will receive their dose of the study drug. They will continue to take this dose for as long as they are on the study.
- The second visit will be 16 weeks after the first one. It will take only 2 hours, and repeat most of the tests from the screening visit.
- The third visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the second visit will be repeated.
- The fourth and final visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the initial study visit (including the scans and the exercise tests) will be repeated.
Read the detailed description
Resveratrol is found in the leaves and skin of grapes, in peanuts and in the roots of the plant polygonum cupsidatum. Although used since early years in Indian Ayurvedic and Chinese medicine, it came into prominence in the 1990 s as it was believed to be the major reason for the positive effect of wine on cardiovascular health and the French Paradox. Since then, studies have shown that resveratrol affects a number of key cellular pathways and molecular targets with a wide range of biological effects. Noted among these are its effects on the blood vessels, cancer, blood clotting, blood sugar control, cognition, muscle activity and inflammation. Resveratrol also may produce some of the same effects as decreased food intake, perhaps through its action on a molecule in the body called Sirtuin, which is important because this is one of the only approaches that has consistently demonstrated beneficial effects on the aging process.
Resveratrol s action and pharmacology has been extensively studied in test tubes, cells, and animals but is only now being explored fully in people. The animal studies include a recent NIA-conducted study in monkeys that demonstrated a reduction in the stiffness of blood vessel over several weeks. Phase 1 and 2 clinical studies in healthy human volunteers or in patients with type II diabetes mellitus have begun to identify possible roles for resveratrol as a dietary supplement and the compound appears to have no harmful effects at doses up to 5 grams per day. There is also growing interest in pharmacological interventions targeting cardiovascular risk factors such as atherosclerosis and type II diabetes to prevent neurodegenerative diseases such as Alzheimer s disease (AD).
We will perform a 12-month trial of resVida (an oral preparation of resveratrol) in 120 randomized overweight/obese people over the age of 50 (40 in each group). This is a Phase 1 and 2 double-blind randomized study. One of two doses of study compound (75mg twice daily or 150mg twice daily) or placebo will be self-administered twice a day for 52 weeks to participants 50 years or older. The primary endpoint will be vascular stiffness (as measured by Pulse Wave Velocity) and the secondary endpoint will be exercise capacity as measured by oxygen utilization (VO2max). Testing will be done on the levels of resveratrol in the blood with different doses of the compound. The study will also include measurements of changes in blood glucose levels, inflammation, and exercise capacity. Targeted, quantitative metabolomics assays in blood will be performed to test whether concentrations of small metabolites previously shown to be associated with arterial stiffness, including free oxysterols, amino acids, acycarnitines and glycerophospholipids are modulated by resveratrol. These studies will provide necessary information for further testing of resVida as a compound that could promote healthy aging.
- Conditions
- Vascular Resistance, Hypertension
- Being tested
- Resveratrol, Placebo
- Keywords
- Vascular Stiffness, Aging, Resveratrol, Aerobic Capacity, Inflammation
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Nutriceutical
PlaceboDrug
2x/day orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | 2x/day orally Receives: Drug: Placebo |
| Resveratrol 1 | Experimental | 75 mg, 2x/day orally Receives: Dietary Supplement: Resveratrol |
| Resveratrol 2 | Experimental | 150 mg, 2x/day orally Receives: Dietary Supplement: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if oral resveratrol administered for 12 months will blunt the aging associated increase in vascular stiffness as measured by Pulse Wave Velocity (PWV).
Decreased rate of age associated arterial stiffening
Measured: Week 16, 32, 52
Secondary outcomes (1)
To determine if oral resveratrol administered for 12 months will improve exercise capacity as measured by MVO2-treadmill.
Changes in aerobic capacity, functional capacity, body composition, muscle energetics, inflammatory markers, glucose metabolism.
Measured: Week 16, 32, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study start14 Jul 2015
- Primary completion31 Jul 2020
- Study completion21 Dec 2022
Why it stopped: The protocol experienced slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ResistanceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ajoy C Karikkineth, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842399
- Sponsor's protocol ID
- 130078
- Other IDs
- 13-AG-0078
- Status last verified
- Dec 2022
- First submitted
- 25 Apr 2013
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial
- ClinicalTrials.gov ID
- NCT01842399
- Acronym / sponsor ID
- 130078
- Conditions
- Vascular Resistance, Hypertension
- Keywords
- Vascular Stiffness, Aging, Resveratrol, Aerobic Capacity, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol experienced slow accrual.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 14 Jul 2015 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 29 Apr 2013 (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.
Background:
- Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it can have positive effects on human health. Lab studies show that it may help lower blood sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test different dose levels of Resveratrol to see what kind of effects it has on older overweight people. It will be tested in healthy volunteers at least 50 years of age.
Objectives:
- To test the effects of different dose levels of Resveratrol on heart and blood vessel health.
Eligibility:
- Healthy overweight nonsmoking volunteers at least 50 years of age.
Design:
- This study will involve a screening visit and four study visits. Some of the study visits will involve overnight inpatient stays.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will be given a list of foods that they should avoid eating while on the study.
- Participants will be separated into three groups. Two groups will take different dose levels of the study drug. The third group will take a placebo.
- At the first study visit, participants will stay in the clinical center overnight for 2 days of tests. They will provide blood and urine samples and have body scans to measure fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be performed. At this visit, they will receive their dose of the study drug. They will continue to take this dose for as long as they are on the study.
- The second visit will be 16 weeks after the first one. It will take only 2 hours, and repeat most of the tests from the screening visit.
- The third visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the second visit will be repeated.
- The fourth and final visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the initial study visit (including the scans and the exercise tests) will be repeated.
Detailed description
Resveratrol is found in the leaves and skin of grapes, in peanuts and in the roots of the plant polygonum cupsidatum. Although used since early years in Indian Ayurvedic and Chinese medicine, it came into prominence in the 1990 s as it was believed to be the major reason for the positive effect of wine on cardiovascular health and the French Paradox. Since then, studies have shown that resveratrol affects a number of key cellular pathways and molecular targets with a wide range of biological effects. Noted among these are its effects on the blood vessels, cancer, blood clotting, blood sugar control, cognition, muscle activity and inflammation. Resveratrol also may produce some of the same effects as decreased food intake, perhaps through its action on a molecule in the body called Sirtuin, which is important because this is one of the only approaches that has consistently demonstrated beneficial effects on the aging process.
Resveratrol s action and pharmacology has been extensively studied in test tubes, cells, and animals but is only now being explored fully in people. The animal studies include a recent NIA-conducted study in monkeys that demonstrated a reduction in the stiffness of blood vessel over several weeks. Phase 1 and 2 clinical studies in healthy human volunteers or in patients with type II diabetes mellitus have begun to identify possible roles for resveratrol as a dietary supplement and the compound appears to have no harmful effects at doses up to 5 grams per day. There is also growing interest in pharmacological interventions targeting cardiovascular risk factors such as atherosclerosis and type II diabetes to prevent neurodegenerative diseases such as Alzheimer s disease (AD).
We will perform a 12-month trial of resVida (an oral preparation of resveratrol) in 120 randomized overweight/obese people over the age of 50 (40 in each group). This is a Phase 1 and 2 double-blind randomized study. One of two doses of study compound (75mg twice daily or 150mg twice daily) or placebo will be self-administered twice a day for 52 weeks to participants 50 years or older. The primary endpoint will be vascular stiffness (as measured by Pulse Wave Velocity) and the secondary endpoint will be exercise capacity as measured by oxygen utilization (VO2max). Testing will be done on the levels of resveratrol in the blood with different doses of the compound. The study will also include measurements of changes in blood glucose levels, inflammation, and exercise capacity. Targeted, quantitative metabolomics assays in blood will be performed to test whether concentrations of small metabolites previously shown to be associated with arterial stiffness, including free oxysterols, amino acids, acycarnitines and glycerophospholipids are modulated by resveratrol. These studies will provide necessary information for further testing of resVida as a compound that could promote healthy aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo2x/day orally |
| Resveratrol 1 | Experimental | Dietary Supplement: Resveratrol75 mg, 2x/day orally |
| Resveratrol 2 | Experimental | Dietary Supplement: Resveratrol150 mg, 2x/day orally |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female, age 50 years or older
- BMI greater than or equal to 25 or less than or equal to 35 and weight less than 300 pounds.
- Participants must provide their own consent.
- Females must be menopausal or have had a bilateral oophorectomy.
- If over 55 years old: no menses for 12 months or longer. Women over 55 years old who haven't had a period for a year will be considered menopausal and do not need a FSH test.
Key exclusion criteria (34 listed)
- Liver Function Tests (LFT) greater than 2 times normal.
- Abnormal thyroid function, as evidenced by Free T3, t4, Free T4 or TSH +/- 5% of the lab reference ranges
- History of diabetes (gestational diabetes ok).
- Hemoglobin A1C greater than 6.5 and/or fasating serum glucose greater than or equal to 126 mg/dL.
- Renal dysfunction (GFR less than 60 mL/min).
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 |
|---|---|---|
| ResveratrolNutriceutical | Dietary supplement | Resveratrol 1, Resveratrol 2 |
| Placebo2x/day orally | Drug | Placebo Comparator |
Primary outcome
To determine if oral resveratrol administered for 12 months will blunt the aging associated increase in vascular stiffness as measured by Pulse Wave Velocity (PWV).
Time frame: Week 16, 32, 52
Decreased rate of age associated arterial stiffening
1 secondary outcome
To determine if oral resveratrol administered for 12 months will improve exercise capacity as measured by MVO2-treadmill.
Time frame: Week 16, 32, 52
Results and safety
The study was stopped early (reason given: The protocol experienced slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
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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.
Ajoy C Karikkineth, M.D. principal investigator
National Institute on Aging (NIA)
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 Resveratrol in people with Vascular Resistance and Hypertension, run by National Institute on Aging (NIA) 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 6 inclusion and 34 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: stopped early, as of the sponsor's last update on 23 Dec 2022. 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 was stopped early (reason given: The protocol experienced slow accrual.). Results are not available in the source record.
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?
To determine if oral resveratrol administered for 12 months will blunt the aging associated increase in vascular stiffness as measured by Pulse Wave Velocity (PWV). (time frame: Week 16, 32, 52). 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 23 Dec 2022.