Clinical trial NCT01400386: Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
Official title: Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.
timeFrame: 18 months
Secondary outcomes:
measure: Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments.
timeFrame: 18 months
Other outcomes:
Locations:
city: Lausanne 26
country: Switzerland
facility: NESTEC/Clinical Development Unit / Metabolic Unit
state: Vaud
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: