Reresveratrol Administered to Healthy Male Subjects (REVAHS)

D

Daniel Doberer

Status

Completed

Conditions

Heme Oxygenase
Healthy Subjects

Treatments

Dietary Supplement: Resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT01768507
ClinPharm 754

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
no medication
Treatment:
Dietary Supplement: Resveratrol
Resveratrol
Experimental group
Description:
Trans-resveratrol (Resveratrol - TerraternalĀ®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.
Treatment:
Dietary Supplement: Resveratrol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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