Reresveratrol Administered to Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy Subjects, Heme Oxygenase

Intervention / Treatment
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* Dietary Supplement: Resveratrol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>no medication | Dietary Supplement: Resveratrol<br>* 5 g (10 capsules) as single oral dose on day 1<br>|
| Experimental: Resveratrol<br>Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period. | Dietary Supplement: Resveratrol<br>* 5 g (10 capsules) as single oral dose on day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximal HO-1 and sirtuin mRNA expression in PBMCs |  | 1 month |