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Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01533857
First received: February 5, 2012
Last updated: December 4, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Plasma concentrations of selected phenolic acids [ Time Frame: up to 30 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma concentration of selected flavonoid metabolites [ Time Frame: up to 30 hrs ] [ Designated as safety issue: No ]
  • Identification of unknown phenolic acids (metabolites of black tea) in plasma [ Time Frame: up to 30 hrs ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533857

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

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01533857     History of Changes
Other Study ID Numbers: FDS-BNH-0379
Study First Received: February 5, 2012
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013