Healthy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTRGC
DIETARY_SUPPLEMENTResveratrol
The equivalent of 150 mg resveratrol
Sponsors
Fruitura Bioscience Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual plasma concentrations of free and conjugated resveratrol | 24 hours | Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported. |
Countries
Israel
Outcome results
None listed