Reresveratrol Administered to Healthy Male Subjects (REVAHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768507
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : September 15, 2016
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna

Brief Summary:
Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to evaluate the HO-1 stimulation of resveratrol in healthy humans.

Condition or disease Intervention/treatment Phase
Healthy Subjects Heme Oxygenase Dietary Supplement: Resveratrol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of the Dietary Supplement Trans-resveratrol on Heme Oxygenase-1 (HO-1) and Sirtuins Expression in PBMCs in Healthy Male Subjects: A Pilot Study.
Study Start Date : March 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
no medication
Dietary Supplement: Resveratrol
5 g (10 capsules) as single oral dose on day 1
Experimental: Resveratrol
Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.
Dietary Supplement: Resveratrol
5 g (10 capsules) as single oral dose on day 1

Primary Outcome Measures :
  1. The maximal HO-1 and sirtuin mRNA expression in PBMCs [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male patient aged between 18 and 45 years (inclusive) at screening.
  • No clinically significant findings on the physical examination at screening.
  • Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
  • Non-smoker (for at least 1 month)
  • Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
  • Negative results from urine drug screen at screening.
  • Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

  • Known hypersensitivity to resveratrol or any excipients of the resveratrol formulation.
  • Treatment with any investigational drug within 3 weeks prior to screening.
  • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of resveratrol.
  • Smoker
  • Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
  • Regularly intake of resveratrol rich food
  • Positive results from the hepatitis serology at screening.
  • Positive results from the HIV serology at screening.
  • Presumed non-compliance.
  • Legal incapacity or limited legal capacity at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768507

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Daniel Doberer

Responsible Party: Daniel Doberer, Investigator, Medical University of Vienna Identifier: NCT01768507     History of Changes
Other Study ID Numbers: ClinPharm 754
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents