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Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533857
First Posted: February 15, 2012
Last Update Posted: August 13, 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):
Unilever R&D
  Purpose
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

Condition Intervention
Cardiovascular Diseases Dietary Supplement: hot water Dietary Supplement: Black tea and phenolic acids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

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

Secondary Outcome Measures:
  • plasma concentration of selected flavonoid metabolites [ Time Frame: up to 30 hrs ]
  • 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


Enrollment: 12
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: February 5, 2012
First Posted: February 15, 2012
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