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OpenTrials
Completed

NCT Number: NCT01533857

Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

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

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Optimed Eurofins

Gières, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy males
  • not smoking

Exclusion criteria

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

Treatment and study plan

hot water

Dietary Supplement

Hot water and placebo capsule

Black tea and phenolic acids

Dietary Supplement

Black tea extract and capsule with phenolic acids

Primary outcomes

  1. Plasma concentrations of selected phenolic acids

    Time frame: up to 30 hrs

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2012
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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