Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

June 4, 2014 updated by: Nestlé
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1000
        • Nestlé Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 65 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose coffee
High dose of polyphenols from soluble coffee
Other: Coffee
Soluble coffee commercially available
Other Names:
  • Soluble coffee
Experimental: Medium dose coffee
Medium dose of polyphenols from soluble coffee
Other: Coffee
Soluble coffee commercially available
Other Names:
  • Soluble coffee
Experimental: Low dose coffee
Low dose of polyphenols from soluble coffee
Other: Coffee
Soluble coffee commercially available
Other Names:
  • Soluble coffee
Experimental: High dose green tea
High dose of green tea polyphenols from infusion
Other: Green tea
Infusion (tea bags) from commercially available green tea
Experimental: Medium dose green tea infusion
Medium dose of green polyphenols from infusion
Other: Green tea
Infusion (tea bags) from commercially available green tea
Experimental: Low dose green tea infusion
low dose of polyphenols from an infusion of green tea
Other: Green tea
Infusion (tea bags) from commercially available green tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites
Time Frame: Measurements done over 24h after ingestion
Measurements done over 24h after ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Measurements done over 12h after ingestion
Measurements done over 12h after ingestion
Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites
Time Frame: Measurements done over 12h after ingestion
Measurements done over 12h after ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maurice Beaumont, M.D., Ph.D., Nestec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 09.06.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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