Coffee Polyphenols Antioxidants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Coffee Antioxidant Efficacy in Humans

Conditions
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Healthy

Intervention / Treatment
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* Other: coffee
* Other: coffee polyphenols mixed with placebo
* Other: maltodextrin enriched with caffeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coffee<br>4 cups/day of 2.5g of coffee each | Other: coffee polyphenols mixed with placebo<br>* coffee polyphenols mixed with placebo<br>Other: maltodextrin enriched with caffeine<br>* maltodextrin enriched with caffeine<br>|
| Active Comparator: coffee polyphenols mixed with placebo<br>4 cups/day of 2.5g of product each | Other: coffee<br>* coffee, placebo enriched with polyphenols and placebo with caffeine<br>Other: maltodextrin enriched with caffeine<br>* maltodextrin enriched with caffeine<br>|
| Placebo Comparator: maltodextrin enriched with caffeine<br>4 cups/day of 2.5g of product each | Other: coffee<br>* coffee, placebo enriched with polyphenols and placebo with caffeine<br>Other: coffee polyphenols mixed with placebo<br>* coffee polyphenols mixed with placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress | The level of oxidative stress will be assessed through measurements of urine and plasma beta isoprostane | Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioavailability of coffee phenolics | plasma kinetics of chlorogenic and phenolic acids. | Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake |