Reresveratrol Administered to Healthy Male Subjects

Not Applicable

Completed

• Conditions: Healthy Subjects; Heme Oxygenase
• Interventions: Dietary Supplement: Resveratrol

• Registration Number: NCT01768507
• Lead Sponsor: Daniel Doberer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-01-13
• Study First Posted: 2013-01-15
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Resveratrol	no medication
Resveratrol	Resveratrol	Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.

Primary Outcome Measures

Name	Time	Method
The maximal HO-1 and sirtuin mRNA expression in PBMCs	1 month

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria