Healthy Subjects Clinical Trial
— REVAHSOfficial 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.
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.
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Daniel Doberer |
Austria,
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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