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Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01089920
First received: March 18, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Green tea
Other: Coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose coffee
High dose of polyphenols from soluble coffee
 Other: Coffee
Soluble coffee commercially available
Other Name: Soluble coffee
Experimental: Medium dose coffee
Medium dose of polyphenols from soluble coffee
 Other: Coffee
Soluble coffee commercially available
Other Name: Soluble coffee
Experimental: Low dose coffee
Low dose of polyphenols from soluble coffee
 Other: Coffee
Soluble coffee commercially available
Other Name: 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
Other Name: 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
Other Name: 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
Other Name: Green tea

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089920

Locations
Switzerland
Nestle Research Center
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Maurice Beaumont, M.D., Ph.D. Nestec
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01089920     History of Changes
Other Study ID Numbers: 09.06.MET
Study First Received: March 18, 2010
Last Updated: June 3, 2013
Health Authority: Switzerland: Swiss Medic

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013