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CompletedNCT01912144Updated Jun 28, 2018

Absorption of Phenolic Acids From Coffee in Humans

An interventional study of Coffee in Bioavailability and Cardiovascular Health Status, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.

Sponsored by University of Leeds · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2012, registered Jul 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bioavailability
  • Cardiovascular Health Status
03

In context

Lead sponsor

University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Other
    coffee

    Coffee beverage

    Other: Coffee

Interventions

  • OtherCoffee
06

What researchers measure

Primary outcomes

  1. Quantitative absorption of chlorogenic acids metabolites

    Analysis using liquid chromatography with or without mass spectrometry, colorimetric and enzyme-linked immunosorbent assays.

    Time frame: up to 7 months

07

Study locations

1 site
  • School of Food Science, University of Leeds
    Leeds, West Yorkshire LS2 9JT, United Kingdom
08

References and documents

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
  • Stevenson DE, Hurst RD. Polyphenolic phytochemicals--just antioxidants or much more? Cell Mol Life Sci. 2007 Nov;64(22):2900-16. doi: 10.1007/s00018-007-7237-1. PubMed 17726576 ↗
  • D'Archivio M, Filesi C, Di Benedetto R, Gargiulo R, Giovannini C, Masella R. Polyphenols, dietary sources and bioavailability. Ann Ist Super Sanita. 2007;43(4):348-61. PubMed 18209268 ↗
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01912144
Lead sponsor
University of Leeds
Responsible party
Gary Williamson (Prof, University of Leeds) — Principal investigator
First posted
Jul 30, 2013
Start date
Sep 1, 2012
Primary completion
Nov 2013
Completion
Jun 27, 2018
Last update
Jun 28, 2018

Study contacts

Gary Williamson, PhD
principal investigator · University of Leeds

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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