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Clinical Trials/NCT01523028
NCT01523028CompletedNot Applicable

Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

Société des Produits Nestlé (SPN)2 sites in 1 country14 target enrollmentStarted: September 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
2
Primary Endpoint
Sum of plasma areas under the curve of coffee phenolics
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. However, some analytical barriers as well as some key aspects of metabolism still remain to be fully elucidated to get the full picture of coffee metabolism and bioavailability. One aspect addressed in the present study is the impact of food matrix in modulating absorption, plasma appearance and urinary excretion of coffee bioactives.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 44 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy men and women
  • •Aged 20-44 years
  • •Caucasian origin
  • •Body mass index (BMI) 19-25 kg/m2
  • •Used to drinking coffee (similar to study coffee) on a daily basis
  • •Being able to tolerate a 48-hour coffee abstinence
  • •Normal oral glucose tolerance test
  • •Having signed the informed consent form

Exclusion Criteria

  • •Taking medication or dietary supplements
  • •Performing a competitive sport
  • •Having metabolic disorders
  • •Long gut transit time (>24 h)
  • •Blood donor
  • •Irregularity in menstrual cycle (for women)
  • •Pregnancy (for women)
  • •Subject who cannot be expected to comply with the study procedures.
  • •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Outcomes

Primary Outcomes

Sum of plasma areas under the curve of coffee phenolics

Time Frame: Measurements over 24h after coffee ingestion

Secondary Outcomes

  • Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids(Measurements done over 24h after coffee ingestion)
  • Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose(Measurements done over 24h after coffee ingestion)

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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