Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Cardiovascular Diseases Clinical Trial

Official title:

Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533857
• Other study ID #: FDS-BNH-0379
• Status: Completed
• Phase: N/A
• First received: February 5, 2012
• Last updated: August 12, 2013
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy males

• not smoking

Exclusion Criteria:

• use of NSAIDS and/or antibiotics

• no blood donation 1 months prior to screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• hot water
Hot water and placebo capsule
• Black tea and phenolic acids
Black tea extract and capsule with phenolic acids

Locations

Country	Name	City	State
France	Optimed Eurofins	Gieres

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of selected phenolic acids		up to 30 hrs	No
Secondary	plasma concentration of selected flavonoid metabolites		up to 30 hrs	No
Secondary	Identification of unknown phenolic acids (metabolites of black tea) in plasma	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	No