Coffee Polyphenols Antioxidants

April 17, 2014 updated by: Nestlé

Coffee Antioxidant Efficacy in Humans

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxidative stress
Time Frame: 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
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
Time Frame: 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.
Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maurice Beaumont, MD, Nestlé Clinical Development Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.07.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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