Reresveratrol Administered to Healthy Male Subjects (REVAHS)

Daniel Doberer

Status: Completed

Conditions: Heme Oxygenase; Healthy Subjects

Treatments: Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01768507

ClinPharm 754

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

no medication

Treatment:

Dietary Supplement: Resveratrol

Resveratrol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Resveratrol