NCT01089920

Brief Summary

Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

March 18, 2010

Last Update Submit

June 4, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites

    Measurements done over 24h after ingestion

Secondary Outcomes (2)

  • Compare Area under the curve (AUC), Maximum plasma concentration (Cmax), Time to reach maximum plasma concentration (Tmax) and half-life (T1/2) of all three doses of coffee for chlorogenic and phenolic acid metabolites

    Measurements done over 12h after ingestion

  • Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites

    Measurements done over 12h after ingestion

Study Arms (6)

High dose coffee

EXPERIMENTAL

High dose of polyphenols from soluble coffee

Other: Coffee

Medium dose coffee

EXPERIMENTAL

Medium dose of polyphenols from soluble coffee

Other: Coffee

Low dose coffee

EXPERIMENTAL

Low dose of polyphenols from soluble coffee

Other: Coffee

High dose green tea

EXPERIMENTAL

High dose of green tea polyphenols from infusion

Other: Green tea

Medium dose green tea infusion

EXPERIMENTAL

Medium dose of green polyphenols from infusion

Other: Green tea

Low dose green tea infusion

EXPERIMENTAL

low dose of polyphenols from an infusion of green tea

Other: Green tea

Interventions

Green teaOTHER

Infusion (tea bags) from commercially available green tea

High dose green teaLow dose green tea infusionMedium dose green tea infusion
CoffeeOTHER

Soluble coffee commercially available

Also known as: Soluble coffee
High dose coffeeLow dose coffeeMedium dose coffee

Eligibility Criteria

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

You may qualify if:

  • years, male and female
  • Healthy as determined by the medical questionnaire and the medical visit
  • Normal weight: BMI 18 - 25
  • Coffee drinkers with an average consumption of 2-5 cups per day
  • Having given informed consent

You may not qualify if:

  • Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
  • Have had a gastrointestinal surgery, except appendicectomy
  • Difficulty to swallow
  • Have a regular consumption of medication
  • Have taken antibiotic therapy within the last 6 months
  • Alcohol consumption \> 2 units a day
  • Smokers (more than 5 cigarettes per day)
  • Have given blood within the last 3 weeks
  • Volunteers who cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial during the last 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestle Research Center

Lausanne, 1000, Switzerland

Location

MeSH Terms

Interventions

TeaCoffee

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Maurice Beaumont, M.D., Ph.D.

    Nestec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

CH(1)