Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Black tea and phenolic acids; Dietary Supplement: hot water

• Registration Number: NCT01533857
• Lead Sponsor: Unilever R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-02
• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-02-12
• Study First Posted: 2012-02-15
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• healthy males
• not smoking

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Black tea	Black tea and phenolic acids	black tea
placebo	hot water	-

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of selected phenolic acids	up to 30 hrs

Secondary Outcome Measures

Name	Time	Method
plasma concentration of selected flavonoid metabolites	up to 30 hrs
Identification of unknown phenolic acids (metabolites of black tea) in plasma	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

Trial Locations

Locations (1)

Optimed Eurofins; 🇫🇷 Gieres, France