NCT01842399

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 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

April 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

July 14, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

5.1 years

First QC Date

April 25, 2013

Last Update Submit

December 21, 2022

Conditions

Vascular ResistanceHypertension

Keywords

Vascular StiffnessAgingResveratrolAerobic CapacityInflammation

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    Week 16, 32, 52

Study Arms (3)

Placebo Comparator

PLACEBO COMPARATOR

2x/day orally

Drug: Placebo

Resveratrol 1

EXPERIMENTAL

75 mg, 2x/day orally

Dietary Supplement: Resveratrol

Resveratrol 2

EXPERIMENTAL

150 mg, 2x/day orally

Dietary Supplement: Resveratrol

Interventions

ResveratrolDIETARY_SUPPLEMENT

Nutriceutical

Resveratrol 1Resveratrol 2
PlaceboDRUG

2x/day orally

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Vitamin supplements containing resveratrol
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionInflammation

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Ajoy C Karikkineth, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2013

First Posted

April 29, 2013

Study Start

July 14, 2015

Primary Completion

July 31, 2020

Study Completion

December 21, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

US(1)