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CompletedNCT01523028Updated Jun 5, 2013

Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

An interventional study of Soluble Coffee in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Germany. Open to participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Taking medication or dietary supplements
  • Smoking
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Coffee, bread and honey

    200 mL coffee + 2 bread rolls + honey

    Other: Soluble Coffee

  • Experimental
    Coffee, bread and peanut butter

    200 mL coffee + 1 bread roll + peanut butter

    Other: Soluble Coffee

  • Experimental
    200 mL black coffee

    Other: Soluble Coffee

Interventions

  • OtherSoluble Coffee

    Amounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast: * 200 mL coffee or * 200 mL coffee + 2 bread rolls + honey * 200 mL coffee + 1 bread roll + peanut butter

06

What researchers measure

Primary outcomes

  1. Sum of plasma areas under the curve of coffee phenolics

    Time frame: Measurements over 24h after coffee ingestion

Secondary outcomes

  1. Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids

    Time frame: Measurements done over 24h after coffee ingestion

  2. Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose

    Time frame: Measurements done over 24h after coffee ingestion

07

Study locations

1 site
  • University of Kaiserslautern
    Kaiserslautern, D-67663, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01523028
Responsible party
Sponsor
First posted
Feb 1, 2012
Start date
Sep 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jun 5, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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