Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01523028
First received: January 27, 2012
Last updated: June 4, 2013
Last verified: June 2013

January 27, 2012
June 4, 2013
September 2011
December 2012   (final data collection date for primary outcome measure)
Sum of plasma areas under the curve of coffee phenolics [ Time Frame: Measurements over 24h after coffee ingestion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01523028 on ClinicalTrials.gov Archive Site
  • Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids [ Time Frame: Measurements done over 24h after coffee ingestion ] [ Designated as safety issue: No ]
  • Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose [ Time Frame: Measurements done over 24h after coffee ingestion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Other: Soluble 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
  • Experimental: Coffee, bread and honey
    200 mL coffee + 2 bread rolls + honey
    Intervention: Other: Soluble Coffee
  • Experimental: Coffee, bread and peanut butter
    200 mL coffee + 1 bread roll + peanut butter
    Intervention: Other: Soluble Coffee
  • Experimental: 200 mL black coffee
    Intervention: Other: Soluble Coffee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2012
December 2012   (final data collection date for primary outcome measure)

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
  • 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.
Both
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01523028
11.12.NRC
Yes
Nestlé
Nestlé
Not Provided
Not Provided
Nestlé
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP