Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

NCT01523028 | Completed DMC

• 1 other identifier: 11.12.NRC
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Sum of plasma areas under the curve of coffee phenolics

  Measurements over 24h after coffee ingestion

Secondary Outcomes (2)

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

  Measurements done over 24h after coffee ingestion

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

  Measurements done over 24h after coffee ingestion

Study Arms (3)

Coffee, bread and honey

EXPERIMENTAL

200 mL coffee + 2 bread rolls + honey

Other: Soluble Coffee

Coffee, bread and peanut butter

EXPERIMENTAL

200 mL coffee + 1 bread roll + peanut butter

Other: Soluble Coffee

200 mL black coffee

EXPERIMENTAL

Other: Soluble Coffee

Interventions

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

200 mL black coffee; Coffee, bread and honey; Coffee, bread and peanut butter

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

University of Kaiserslautern

Kaiserslautern, D-67663, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

DE (1)