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Completed

NCT Number: NCT01768507

Reresveratrol Administered to Healthy Male Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Dietary Supplement

5 g (10 capsules) as single oral dose on day 1

Primary outcomes

  1. The maximal HO-1 and sirtuin mRNA expression in PBMCs

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Daniel Doberer

Other

Registry information

Official study 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.

Acronym: REVAHS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2013
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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