Pharmacokinetics of Resveratrol Comprising Products

NCT ID: NCT01747252

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RGC1

RGC containing the equivalent of 50 mg resveratrol

Group Type EXPERIMENTAL

RGC

Intervention Type DIETARY_SUPPLEMENT

Resveratrol

The equivalent of 150 mg resveratrol

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

The equivalent of 150 mg resveratrol

RGC2

RGC containing the equivalent of 150 mg resveratrol

Group Type EXPERIMENTAL

RGC

Intervention Type DIETARY_SUPPLEMENT

Interventions

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RGC

Intervention Type DIETARY_SUPPLEMENT

RGC

Intervention Type DIETARY_SUPPLEMENT

Resveratrol

The equivalent of 150 mg resveratrol

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Transmax (Biotivia Ltd.)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fruitura Bioscience Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BioStudies Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 24827888 (View on PubMed)

Other Identifiers

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08/12

Identifier Type: -

Identifier Source: org_study_id

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