ISRCTN ISRCTN04271658
DOI https://doi.org/10.1186/ISRCTN04271658
Secondary identifying numbers 2011017
Submission date
03/07/2014
Registration date
23/07/2014
Last edited
24/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Oranges are one of the most popular foods in the world and are commonly enjoyed as a fresh fruit and as a juice. They are a great source of many nutrients including polyphenolic compounds called flavanones. There is evidence to suggest that flavanones may be, in part, responsible for a potentially protective effect of orange juice against cardiovascular (heart) disease. Flavanones, like antioxidants, 'mop up' free radicals, molecules that damage blood vessels and cause arteries to become clogged up with cholesterol. Once drunk, the flavanones in orange juice are broken down into metabolites in the digestive system before they are then taken into the blood stream. It is, therefore, the effects of these metabolites that lead to the protective effects against cardiovascular disease (CD). The eventual aim is to understand how these metabolites work in the body, but here we are working towards identifying and quantifying those that are produced in the digestive system (namely the gastrointestinal tract) before they enter the bloodstream. In our previous work, we have looked at the appearance of flavonone metabolites in the blood after the drinking of some orange juice. This study will look at their excretion (removal from the body) in the urine 0-24 hours after the drinking of orange juice as this gives us a much better overall measure of how much has been absorbed.

Who can participate?
Healthy volunteers between 20 and 60 years old, non-smokers and not under medication.

What does the study involve?
Volunteers are required to follow a diet low in polyphenolic compounds for 48 hours before the start of the study and for 24 hours after supplementation, avoiding fruits, vegetables, high-fibre products, and drinks such as tea, coffee, fruit juice, and wine. Then, after an overnight fast, each person drinks 250 mL of pulp-enriched orange juice. A light breakfast of white bread, cheese, ham and milk is provided 2 hours after the orange juice has been drunk. Two weeks later, the volunteers drink 250 mL of a placebo drink. All urine is collected on five occasions over the periods 0, 0-2, 2-5, 5-10 and 10-24 hours after drinking either the orange juice or placebo drink.

What are the possible benefits and risks of participating?
There are no potential risks or benefits to taking part in the study.

Where is the study run from?
The University of Glasgow (UK)

When is the study starting and how long is it expected to run for?
January 2012 to December 2012

Who is funding the study?
The Coca-Cola Company (USA)

Who is the main contact?
Professor Mike Lean
Mike.Lean@glasgow.ac.uk

Contact information

Prof Mike Lean
Scientific

School of Medicine - GRI Campus
College of Medical, Veterinary and Life Sciences
University of Glasgow
2nd Floor, New Lister Building
Glasgow Royal Infirmary
10-16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Email Mike.Lean@glasgow.ac.uk

Study information

Study designCross-over non-randomised intervention
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleBioavailabilty of Orange Juice polyphenols: a cross-over, non-randomised intervention
Study acronymBOJ
Study objectivesIncluding the detection and quantification of flavanone metabolites and their colonic microflora-mediated breakdown products in the investigation of orange juice polyphenol absorption and metabolism will lead to a better understanding of their real bioavailability in humans.
Ethics approval(s)University of Glasgow, MVLS College Ethics Committee, 21/12/2011, Project Number: 2011017
Health condition(s) or problem(s) studiedBioavailabilty of orange juice polyphenols
InterventionEach subject will drink 250 ml of pulp-enriched orange juice. A light breakfast consisting of white bread, cheese, ham and milk will be provided 2 h after orange juice intake. After a wash-out period of 2 weeks, the volunteers will ingest 250 ml of a placebo drink. Following supplementation, all urine will be collected over five time periods (0, 0-2, 2-5, 5-10 and 10-24 hours).
Intervention typeOther
Primary outcome measureThe absolute bioavailability of orange juice phenolics will be the primary outcome of this study. Polyphenol metabolites and catabolites will be identified and quantified in urine collected over five time periods (0, 0-2, 2-5, 5-10 and 10-24 hours) following supplementation, using high-performance liquid chromatography coupled with tandem mass spectrometry and gas chromatography coupled with mass spectrometry.
Secondary outcome measuresN/A
Overall study start date03/01/2012
Completion date01/12/2012

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants12
Key inclusion criteria1. Healthy men and women.
2. Age 20-65 years
Key exclusion criteria1. Smoking
2. On no medication
Date of first enrolment03/01/2012
Date of final enrolment01/12/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom

Sponsor information

The Coca-Cola Company (USA)
Industry

c/o Dr Susan Roberts
Atlanta
GA 30313
United States of America

Email suroberts@coca-cola.com
Website http://us.coca-cola.com
ROR logo "ROR" https://ror.org/00yc8qw13

Funders

Funder type

Industry

The Coca-Cola Company (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 Yes No