Coffee Polyphenols Antioxidants
Coffee Antioxidant Efficacy in Humans
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Mar 2011
Longer than P75 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 21, 2014
April 1, 2014
1.1 years
April 8, 2013
April 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Coffee
EXPERIMENTAL4 cups/day of 2.5g of coffee each
coffee polyphenols mixed with placebo
ACTIVE COMPARATOR4 cups/day of 2.5g of product each
maltodextrin enriched with caffeine
PLACEBO COMPARATOR4 cups/day of 2.5g of product each
Interventions
coffee, placebo enriched with polyphenols and placebo with caffeine
coffee polyphenols mixed with placebo
maltodextrin enriched with caffeine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Beaumont, MD
Nestlé Clinical Development Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 16, 2013
Study Start
March 1, 2011
Primary Completion
April 1, 2012
Study Completion
June 1, 2013
Last Updated
April 21, 2014
Record last verified: 2014-04