NCT01533857

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 13, 2013

Status Verified

November 1, 2012

Enrollment Period

Same day

First QC Date

February 5, 2012

Last Update Submit

August 12, 2013

Conditions

Cardiovascular Diseases

Keywords

Black teaphenolic acids

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of selected phenolic acids

    up to 30 hrs

Secondary Outcomes (2)

  • 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

Study Arms (2)

Black tea

EXPERIMENTAL

black tea

Dietary Supplement: Black tea and phenolic acids

placebo

PLACEBO COMPARATOR
Dietary Supplement: hot water

Interventions

hot waterDIETARY_SUPPLEMENT

Hot water and placebo capsule

placebo
Black tea and phenolic acidsDIETARY_SUPPLEMENT

Black tea extract and capsule with phenolic acids

Black tea

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy males
  • not smoking

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimed Eurofins

Gières, France

Location

Related Publications (1)

  • 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.

    PMID: 24673575DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yves Donazzolo, MD

    Eurofins Optimed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

November 1, 2012

Last Updated

August 13, 2013

Record last verified: 2012-11

Locations

FR(1)