Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01400386
• Date of registration: 21/07/2011
• Prospective Registration: No
• Primary sponsor: Nestlé
• Public title: Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
• Scientific title: Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
• Date of first enrolment: November 2010
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01400386
• 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
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Maurice Beaumont, MD, Ph.D
• Affiliation: Nestlé

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: Coffee bioavailability trial

Primary Outcome(s)

Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments. [Time Frame: 18 months]

Secondary Outcome(s)

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]

Secondary ID(s)

10.04.Met

Source(s) of Monetary Support

Please refer to primary and secondary sponsors