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Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

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ClinicalTrials.gov Identifier: NCT01533857
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: hot water Dietary Supplement: Black tea and phenolic acids Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
Study Start Date : February 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Black tea
black tea
Dietary Supplement: Black tea and phenolic acids
Black tea extract and capsule with phenolic acids
Placebo Comparator: placebo Dietary Supplement: hot water
Hot water and placebo capsule



Primary Outcome Measures :
  1. Plasma concentrations of selected phenolic acids [ Time Frame: up to 30 hrs ]

Secondary Outcome Measures :
  1. plasma concentration of selected flavonoid metabolites [ Time Frame: up to 30 hrs ]
  2. Identification of unknown phenolic acids (metabolites of black tea) in plasma [ Time Frame: up to 30 hrs ]
    It is still largely unknown which metabolites are formed in-vivo after black tea ingestions and circulating in human plasma. Untargeted profiling using LC-MS of plasma samples will be used to identify yet unknown polyphenols / phenolics and their conjugates in plasma and thus extent the hit-list of known metabolites in circulation after black tea consumption



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males
  • not smoking

Exclusion Criteria:

  • use of NSAIDS and/or antibiotics
  • no blood donation 1 months prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533857


Locations
France
Optimed Eurofins
Gieres, France
Sponsors and Collaborators
Unilever R&D
Investigators
Principal Investigator: Yves Donazzolo, MD Eurofins Optimed

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01533857     History of Changes
Other Study ID Numbers: FDS-BNH-0379
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: November 2012

Keywords provided by Unilever R&D:
Black tea
phenolic acids

Additional relevant MeSH terms:
Cardiovascular Diseases