Status:
TERMINATED
Resveratrol and Cardiovascular Health in the Elderly
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Vascular Resistance
Hypertension
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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 suga...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
July 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01842399
Start Date
July 14 2015
End Date
December 21 2022
Last Update
December 23 2022
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224