Absorption of Phenolic Acids From Coffee in Humans

NCT ID: NCT01912144

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2018-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bioavailability Cardiovascular Health Status

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

coffee

Coffee beverage

Group Type OTHER

Coffee

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coffee

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gary Williamson

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary Williamson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Food Science, University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17726576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18209268 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEEC 10-035

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Coffee Polyphenols Antioxidants
NCT01832662 COMPLETED NA
Interindividual Variation in Response to Green Coffee
NCT06204445 ACTIVE_NOT_RECRUITING NA
Polyphenols and Endothelial Function
NCT00619749 TERMINATED PHASE3