Reresveratrol Administered to Healthy Male Subjects

NCT01768507 | Completed

• 1 other identifier: ClinPharm 754
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Heme Oxygenase

Outcome Measures

Primary Outcomes (1)

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

  1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

no medication

Dietary Supplement: Resveratrol

Resveratrol

EXPERIMENTAL

Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.

Dietary Supplement: Resveratrol

Interventions

Resveratrol DIETARY_SUPPLEMENT

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

Placebo; Resveratrol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Doberer: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: January 15, 2013
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

AU (1)