Healthy
Conditions
Brief summary
Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo
Detailed description
This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.
Interventions
OTHERcoffee
coffee, placebo enriched with polyphenols and placebo with caffeine
OTHERcoffee polyphenols mixed with placebo
coffee polyphenols mixed with placebo
OTHERmaltodextrin enriched with caffeine
maltodextrin enriched with caffeine
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 20 - 70 years, male and female * healthy * BMI 19 - 29 kg/m2 * Coffee drinkers with an average consumption of 1-3 cups per day * having given informed consent
Exclusion criteria
* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer- Have had a gastrointestinal surgery, except appendicectomy * 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 (more than 5 cigarettes per day) * Have given blood within the last 3 weeks * 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 | Description |
|---|---|---|
| oxidative stress | Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake | The level of oxidative stress will be assessed through measurements of urine and plasma beta isoprostane |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bioavailability of coffee phenolics | Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake | plasma kinetics of chlorogenic and phenolic acids. |
Outcome results
None listed