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: August 12, 2013
Last verified: November 2012
  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:


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
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: 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: August 12, 2013
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 August 25, 2014