Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

August 12, 2013 updated by: Unilever R&D
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gieres, France
        • Optimed Eurofins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males
  • not smoking

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: hot water
Hot water and placebo capsule
Experimental: Black tea
black tea
Dietary supplement: Black tea and phenolic acids
Black tea extract and capsule with phenolic acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of selected phenolic acids
Time Frame: up to 30 hrs
up to 30 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma concentration of selected flavonoid metabolites
Time Frame: up to 30 hrs
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
up to 30 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 5, 2012

First Submitted That Met QC Criteria

February 12, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDS-BNH-0379

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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