Reresveratrol Administered to Healthy Male Subjects

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768507

Acronym

REVAHS

Enrollment

Registered

2013-01-15

Start date

2011-03-31

Completion date

2011-03-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Heme Oxygenase

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.

Interventions

DIETARY_SUPPLEMENTResveratrol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
The maximal HO-1 and sirtuin mRNA expression in PBMCs	1 month

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026