Coffee Polyphenols Antioxidants

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: coffee polyphenols mixed with placebo; Other: coffee; Other: maltodextrin enriched with caffeine

• Registration Number: NCT01832662
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Study Completion: 2013-06
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-17
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coffee	coffee polyphenols mixed with placebo	4 cups/day of 2.5g of coffee each
Coffee	maltodextrin enriched with caffeine	4 cups/day of 2.5g of coffee each
coffee polyphenols mixed with placebo	coffee	4 cups/day of 2.5g of product each
coffee polyphenols mixed with placebo	maltodextrin enriched with caffeine	4 cups/day of 2.5g of product each
maltodextrin enriched with caffeine	coffee	4 cups/day of 2.5g of product each
maltodextrin enriched with caffeine	coffee polyphenols mixed with placebo	4 cups/day of 2.5g of product each

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.