Resveratrol and Cardiovascular Health in the Elderly
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 50 - 100 |
| Updated: | 10/18/2018 |
| Start Date: | February 9, 2013 |
| End Date: | September 1, 2019 |
| Contact: | Denise L Melvin, R.N. |
| Email: | dm381j@nih.gov |
| Phone: | (410) 350-3924 |
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.
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.
- 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.
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
nutritional 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.
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
nutritional 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.
- INCLUSION CRITERIA:
Male or Female, age 50 years or older, BMI 25-35.
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.
EXCLUSION CRITERIA:
Liver Function Tests (LFT) greater than 2 times normal.
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).
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
Anti-hypertensive medications Metoprolol (Lopressor), Carvedilol (Coreg), Nifedipine
(Procardia, Adalat), Verapamil (Verelan,Calan, Covera), Lisinopril (Prinivil, Zestril),
Captopril (Capoten), Losartan (Cozaar), Irbesartan (Avapro), 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 2.5 glasses of wine) for men or 15
grams for women (~1.5 glasses of wine) 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.
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