Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

NCT ID: NCT01533857

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Cardiovascular Diseases

Keywords

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Black tea phenolic acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Black tea

black tea

Group Type EXPERIMENTAL

Black tea and phenolic acids

Intervention Type DIETARY_SUPPLEMENT

Black tea extract and capsule with phenolic acids

placebo

Group Type PLACEBO_COMPARATOR

hot water

Intervention Type DIETARY_SUPPLEMENT

Hot water and placebo capsule

Interventions

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hot water

Hot water and placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Black tea and phenolic acids

Black tea extract and capsule with phenolic acids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy males
* not smoking

Exclusion Criteria

* use of NSAIDS and/or antibiotics
* no blood donation 1 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Donazzolo, MD

Role: PRINCIPAL_INVESTIGATOR

Eurofins Optimed

Locations

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Optimed Eurofins

Gières, , France

Site Status

Countries

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France

References

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van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.

Reference Type DERIVED
PMID: 24673575 (View on PubMed)

Other Identifiers

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FDS-BNH-0379

Identifier Type: -

Identifier Source: org_study_id