Overview

This trial is active, not recruiting.

Conditions bioavailability, cardiovascular health status
Treatment coffee
Sponsor University of Leeds
Start date September 2012
End date October 2013
Trial size 60 participants
Trial identifier NCT01912144, MEEC 10-035

Summary

Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and are characterised by a phenol ring in their structure. The phenolic compounds we are going to focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant activity (2).

HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3) and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few studies suggest protective effects for cardiovascular diseases (5), neurodegenerative diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate between these and risk in humans of development or progression of particular health conditions, more human studies are therefore needed.

We aim to compare people that metabolise the best CGAs from coffee to those that metabolise them the least well. This will be achieved by measuring the metabolites in urine. The effect of CGAs on the human body does not only depend on the amount ingested, but also on the quality of the metabolism, we therefore also want to determine which mechanisms are responsible for inter-individual variations in order to identify any link with health biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.

For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers will be recruited at the School of Food Science & Nutrition. If they meet the selection criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36 hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low in phenolic acids and keep a record of their meals. On the first day of the study, a single dose of coffee rich in antioxidants will be given to the participant and urine will be collected from that time until 36 hours after coffee consumption. Participants will be followed again after 5 to 6 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Other)
Coffee beverage
coffee

Primary Outcomes

Measure
Quantitative absorption of chlorogenic acids metabolites
time frame: up to 7 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Age 18-70 years - Normal Body Mass Index (BMI) 18-29 kg/m2 - Non-smoker, former or weak smoker (max. 5 cigarettes per day) - No more than 4 alcoholic units as a regular and daily consumption Exclusion Criteria: - diagnosed chronic disease (e.g. pancreas, kidneys, liver, heart) - haemophilia - long term prescribed medication (contraceptive medication allowed) - previous GI (gastrointestinal) tract operation - pregnant or breast feeding

Additional Information

Official title Bioavailability of Coffee Phenolic Acids and Cardiovascular Health in Healthy Humans.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University of Leeds.