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OpenTrials
Completed

NCT Number: NCT01832662

Coffee Polyphenols Antioxidants

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

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Key information

Conditions

Healthy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coffee

Other

coffee, placebo enriched with polyphenols and placebo with caffeine

coffee polyphenols mixed with placebo

Other

coffee polyphenols mixed with placebo

maltodextrin enriched with caffeine

Other

maltodextrin enriched with caffeine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Coffee Antioxidant Efficacy in Humans

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 16, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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