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Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01400386
First received: July 21, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Coffee bioavailability trial

Study Type: Interventional
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
Official Title: Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soluble coffee 1 Other: Coffee bioavailability trial
Coffee bioavailability trial
Experimental: Soluble coffee 2 Other: Coffee bioavailability trial
Coffee bioavailability trial
Experimental: Soluble coffee 3 Other: Coffee bioavailability trial
Coffee bioavailability trial
Experimental: Soluble coffee 4 Other: Coffee bioavailability trial
Coffee bioavailability trial

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400386

Locations
Switzerland
NESTEC/Clinical Development Unit / Metabolic Unit
Lausanne 26, Vaud, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Maurice Beaumont, MD, Ph.D Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01400386     History of Changes
Other Study ID Numbers: 10.04.Met
Study First Received: July 21, 2011
Last Updated: May 15, 2013
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 23, 2013