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Absorption of Phenolic Acids From Coffee in Humans

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ClinicalTrials.gov Identifier: NCT01912144
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Williamson, University of Leeds

Brief 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.


Condition or disease Intervention/treatment Phase
Bioavailability Cardiovascular Health Status Other: Coffee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bioavailability of Coffee Phenolic Acids and Cardiovascular Health in Healthy Humans.
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : June 27, 2018

Arm Intervention/treatment
coffee
Coffee beverage
Other: Coffee



Primary Outcome Measures :
  1. Quantitative absorption of chlorogenic acids metabolites [ Time Frame: up to 7 months ]
    Analysis using liquid chromatography with or without mass spectrometry, colorimetric and enzyme-linked immunosorbent assays.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912144


Locations
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United Kingdom
School of Food Science, University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Gary Williamson, PhD University of Leeds

Publications:
M.N. Clifford, J. Sci. Food Agric. 80 (2000) 1033-1043.] [Clifford MN, Chlorogenic acids and other cinnamates-nature, occurrence and dietary burden. Journal of the Science of Food and Agriculture 1999, 79(3), 362-372
Stalmach et al. 2006, On-line HPLC analysis of the antioxidant activity of phenolic compounds in brewed paper-filtered coffee. Brasil J Plant Physiol 18:253-262
Stanner 2005, Cardiovascular disease: Diet, Nutrition and emerging risk factors. The report of the british nutrition foundation task force. Blackwell Science for the British nutrition foundation: Oxford, UK

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Responsible Party: Gary Williamson, Prof, University of Leeds
ClinicalTrials.gov Identifier: NCT01912144     History of Changes
Other Study ID Numbers: MEEC 10-035
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018