Pharmacokinetics of Resveratrol Comprising Products
Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 9, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 3, 2013
May 1, 2013
2 months
December 9, 2012
May 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Individual plasma concentrations of free and conjugated resveratrol
Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported.
24 hours
Study Arms (3)
RGC1
EXPERIMENTALRGC containing the equivalent of 50 mg resveratrol
Resveratrol
ACTIVE COMPARATORThe equivalent of 150 mg resveratrol
RGC2
EXPERIMENTALRGC containing the equivalent of 150 mg resveratrol
Interventions
The equivalent of 150 mg resveratrol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BioStudies Center
Beersheba, 84101, Israel
Related Publications (1)
Azachi M, Yatuv R, Katz A, Hagay Y, Danon A. A novel red grape cells complex: health effects and bioavailability of natural resveratrol. Int J Food Sci Nutr. 2014 Nov;65(7):848-55. doi: 10.3109/09637486.2014.917152. Epub 2014 May 15.
PMID: 24827888DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2012
First Posted
December 11, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2012
Study Completion
March 1, 2013
Last Updated
May 3, 2013
Record last verified: 2013-05