Pharmacokinetics of Resveratrol Comprising Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fruitura Bioscience Ltd.
ClinicalTrials.gov Identifier:
NCT01747252
First received: December 9, 2012
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: RGC
Dietary Supplement: Resveratrol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Fruitura Bioscience Ltd.:

Primary Outcome Measures:
  • Individual plasma concentrations of free and conjugated resveratrol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported.


Enrollment: 15
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RGC1
RGC containing the equivalent of 50 mg resveratrol
Dietary Supplement: RGC
Active Comparator: Resveratrol
The equivalent of 150 mg resveratrol
Dietary Supplement: Resveratrol
The equivalent of 150 mg resveratrol
Other Name: Transmax (Biotivia Ltd.)
Experimental: RGC2
RGC containing the equivalent of 150 mg resveratrol
Dietary Supplement: RGC

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747252

Locations
Israel
BioStudies Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Fruitura Bioscience Ltd.
  More Information

No publications provided

Responsible Party: Fruitura Bioscience Ltd.
ClinicalTrials.gov Identifier: NCT01747252     History of Changes
Other Study ID Numbers: 08/12
Study First Received: December 9, 2012
Last Updated: May 1, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014