Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

June 4, 2013 updated by: Société des Produits Nestlé (SPN)
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaiserslautern, Germany, D-67663
        • University of Kaiserslautern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coffee, bread and honey
200 mL coffee + 2 bread rolls + honey

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sum of plasma areas under the curve of coffee phenolics
Time Frame: Measurements over 24h after coffee ingestion
Measurements over 24h after coffee ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids
Time Frame: Measurements done over 24h after coffee ingestion
Measurements done over 24h after coffee ingestion
Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose
Time Frame: Measurements done over 24h after coffee ingestion
Measurements done over 24h after coffee ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 11.12.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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