Reresveratrol Administered to Healthy Male Subjects

Healthy Subjects Clinical Trial

— REVAHS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768507
• Other study ID #: ClinPharm 754
• Status: Completed
• Phase: N/A
• First received: January 13, 2013
• Last updated: September 14, 2016
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: September 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects
• Heme Oxygenase

Intervention

Dietary Supplement:
• Resveratrol
5 g (10 capsules) as single oral dose on day 1

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Doberer

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal HO-1 and sirtuin mRNA expression in PBMCs		1 month	No