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Trial record 18 of 737 for:    Area Under Curve AND Bioavailability

Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01089920
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE March 18, 2010
First Posted Date  ICMJE March 19, 2010
Last Update Posted Date June 5, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2010)
Compare plasma AUC of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites [ Time Frame: Measurements done over 24h after ingestion ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2010)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Official Title  ICMJE Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Green tea
    Infusion (tea bags) from commercially available green tea
  • Other: Coffee
    Soluble coffee commercially available
    Other Name: Soluble coffee
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2010)
24
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089920
Other Study ID Numbers  ICMJE 09.06.MET
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maurice Beaumont, M.D., Ph.D. Nestec
PRS Account Nestlé
Verification Date June 2014

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