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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768507
Other study ID # ClinPharm 754
Secondary ID
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


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
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