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Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01523028
First received: January 27, 2012
Last updated: November 14, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Soluble Coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Sum of plasma areas under the curve of coffee phenolics [ Time Frame: Measurements over 24h after coffee ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coffee, bread and honey
200 mL coffee + 2 bread rolls + honey
 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 peanut butter
200 mL coffee + 1 bread roll + peanut butter
 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: 200 mL black coffee 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

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523028

Locations
Germany
University of Kaiserslautern
Kaiserslautern, Germany, D-67663
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01523028     History of Changes
Other Study ID Numbers: 11.12.NRC
Study First Received: January 27, 2012
Last Updated: November 14, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on May 16, 2013