Pharmacokinetics of Resveratrol Comprising Products

Fruitura Bioscience

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: RGC; Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747252

08/12

Details and patient eligibility

About

This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC) containing resveratrol compared with a reference. RGC will be administered as single oral dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total conjugates will be analyzed.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 18-55 years;
• BMI >/= 19 and </= 30
• non smoking
• without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease
• normal physical and laboratory examinations

Exclusion criteria

• History or evidence of alcohol or drug abuse
• subjects receiving chronic medication
• unusual dietary habits or a recent change in body weight
• acute medical situation 48 hours prior to initiation of the study
• poor venous access
• Subjects participated in a trial or donated blood within 4 weeks before initiation of the study

Trial design

15 participants in 3 patient groups

RGC1

Experimental group

Description:

RGC containing the equivalent of 50 mg resveratrol

Treatment:

Dietary Supplement: RGC

Dietary Supplement: RGC

Resveratrol

Active Comparator group

Description:

The equivalent of 150 mg resveratrol

Treatment:

Dietary Supplement: Resveratrol

RGC2

Experimental group

Description:

RGC containing the equivalent of 150 mg resveratrol

Treatment:

Dietary Supplement: RGC

Dietary Supplement: RGC