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OpenTrials
Completed

NCT Number: NCT01089920

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestle Research Center

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea

Other

Infusion (tea bags) from commercially available green tea

Coffee

Other

Soluble coffee commercially available

Other names: Soluble coffee

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2010
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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