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OpenTrials
Completed

NCT Number: NCT01523028

Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

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.

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Key information

Conditions

Healthy

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kaiserslautern

Kaiserslautern, D-67663, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Soluble Coffee

Other

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

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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Jun 5, 2013

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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