Healthy
Conditions
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.
Interventions
OTHERCoffee bioavailability trial
Coffee bioavailability trial
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments. | 18 months |
Countries
Switzerland
Outcome results
None listed