Reresveratrol Administered to Healthy Male Subjects (REVAHS)
This study has been completed.
Sponsor:
Daniel Doberer
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01768507
First received: January 13, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Subjects Heme Oxygenase |
Dietary Supplement: Resveratrol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Dietary Supplements
Drug Information available for:
Resveratrol
U.S. FDA Resources
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- The maximal HO-1 and sirtuin mRNA expression in PBMCs [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
no medication
|
|
|
Experimental: Resveratrol
Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.
|
Dietary Supplement: Resveratrol
5 g (10 capsules) as single oral dose on day 1
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Daniel Doberer, Investigator, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01768507 History of Changes |
| Other Study ID Numbers: | ClinPharm 754 |
| Study First Received: | January 13, 2013 |
| Last Updated: | January 13, 2013 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Additional relevant MeSH terms:
|
Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013