Absorption of Phenolic Acids From Coffee in Humans

Bioavailability Clinical Trial

Official title:

Bioavailability of Coffee Phenolic Acids and Cardiovascular Health in Healthy Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912144
• Other study ID #: MEEC 10-035
• Status: Completed
• Phase: N/A
• Start date: September 1, 2012
• Est. completion date: June 27, 2018

Study information

• Verified date: June 2018
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 27, 2018
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability
• Cardiovascular Health Status

Intervention

Other:
• Coffee

Locations

Country	Name	City	State
United Kingdom	School of Food Science, University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. Review. — View Citation

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

Stevenson DE, Hurst RD. Polyphenolic phytochemicals--just antioxidants or much more? Cell Mol Life Sci. 2007 Nov;64(22):2900-16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative absorption of chlorogenic acids metabolites	Analysis using liquid chromatography with or without mass spectrometry, colorimetric and enzyme-linked immunosorbent assays.	up to 7 months