Reresveratrol Administered to Healthy Male Subjects

NCT ID: NCT01768507

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-03-31

Brief 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.

Conditions

Healthy Subjects; Heme Oxygenase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Placebo

no medication

Group Type: PLACEBO_COMPARATOR

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

5 g (10 capsules) as single oral dose on day 1

Resveratrol

Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

5 g (10 capsules) as single oral dose on day 1

Interventions

Resveratrol

5 g (10 capsules) as single oral dose on day 1

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daniel Doberer

OTHER

Sponsor Role: lead

Responsible Party

Daniel Doberer

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

ClinPharm 754

Identifier Type: -

Identifier Source: org_study_id