Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

Healthy Clinical Trial

Official title:

Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400386
• Other study ID #: 10.04.Met
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: May 21, 2014
• Start date: November 2010
• Est. completion date: June 2013

Study information

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

Clinical Trial Summary

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roasting degrees. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.

Description:

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roast levels. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at different roast levels.

After medical examination and approval, subjects will be randomly assigned to one of the four coffee treatments. Each study period correspond to the ingestion of one the treatments and study periods are separated by a one week washout period. Blood will be taken as a time course for 24h while urine will be collected for 30h. Investigators are also blinded with respect to the dose and the treatment given to the subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 20 - 60 years, male and female

• healthy as determined by the medical questionnaire and the medical visit

• normal weight: BMI 19 - 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

• food allergy

• Have had a major gastrointestinal surgery

• 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 > 5 cigarettes a day

• Have given blood within the last 3 weeks before the start of the study

• 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Coffee bioavailability trial
Coffee bioavailability trial

Locations

Country	Name	City	State
Switzerland	NESTEC/Clinical Development Unit / Metabolic Unit	Lausanne 26	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.		18 months	No
Secondary	Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments.		18 months	No