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Pharmacokinetics of Resveratrol Comprising Products

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747252
First Posted: December 11, 2012
Last Update Posted: May 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fruitura Bioscience Ltd.
December 9, 2012
December 11, 2012
May 3, 2013
August 2012
October 2012   (Final data collection date for primary outcome measure)
Individual plasma concentrations of free and conjugated resveratrol [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01747252 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of Resveratrol Comprising Products
Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Healthy
  • Dietary Supplement: RGC
  • Dietary Supplement: Resveratrol
    The equivalent of 150 mg resveratrol
    Other Name: Transmax (Biotivia Ltd.)
  • Experimental: RGC1
    RGC containing the equivalent of 50 mg resveratrol
    Intervention: Dietary Supplement: RGC
  • Active Comparator: Resveratrol
    The equivalent of 150 mg resveratrol
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: RGC2
    RGC containing the equivalent of 150 mg resveratrol
    Intervention: Dietary Supplement: RGC
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2013
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01747252
08/12
No
Not Provided
Not Provided
Fruitura Bioscience Ltd.
Fruitura Bioscience Ltd.
Not Provided
Not Provided
Fruitura Bioscience Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP