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

March 18, 2010
June 3, 2013
September 2009
March 2011   (final data collection date for primary outcome measure)
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 ]
Compare plasma 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 ]
Complete list of historical versions of study NCT01089920 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Compare AUC, Cmax, Tmax and 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 ]
Not Provided
Not Provided
 
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Healthy
  • Other: Green tea
    Infusion (tea bags) from commercially available green tea
    Other Name: Green tea
  • Other: Coffee
    Soluble coffee commercially available
    Other Name: Soluble coffee
  • Experimental: High dose coffee
    High dose of polyphenols from soluble coffee
    Intervention: Other: Coffee
  • Experimental: Medium dose coffee
    Medium dose of polyphenols from soluble coffee
    Intervention: Other: Coffee
  • Experimental: Low dose coffee
    Low dose of polyphenols from soluble coffee
    Intervention: Other: Coffee
  • Experimental: High dose green tea
    High dose of green tea polyphenols from infusion
    Intervention: Other: Green tea
  • Experimental: Medium dose green tea infusion
    Medium dose of green polyphenols from infusion
    Intervention: Other: Green tea
  • Experimental: Low dose green tea infusion
    low dose of polyphenols from an infusion of green tea
    Intervention: Other: Green tea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
June 2013
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01089920
09.06.MET
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Maurice Beaumont, M.D., Ph.D. Nestec
Nestlé
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP