Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

Healthy Clinical Trial

Official title:

Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089920
• Other study ID #: 09.06.MET
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: June 4, 2014
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: June 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Medic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Green tea
Infusion (tea bags) from commercially available green tea
• Coffee
Soluble coffee commercially available

Locations

Country	Name	City	State
Switzerland	Nestle Research Center	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites		Measurements done over 24h after ingestion	No
Secondary	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		Measurements done over 12h after ingestion	No
Secondary	Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites		Measurements done over 12h after ingestion	No