Bioavailability of virgin olive oil bioactive compounds and medium term impact on biomarkers of health

ISRCTN ISRCTN93136746
DOI https://doi.org/10.1186/ISRCTN93136746
Secondary identifying numbers 2012071
Submission date
02/06/2014
Registration date
09/07/2014
Last edited
19/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Virgin olive oil is widely used in Mediterranean food and has been associated with health benefits such as protection against heart disease. For many years, the beneficial properties of olive oil were attributed to a type of fat named oleic acid. Besides containing high quantities of oleic acid, some olive oils contain small molecules called phenolic compounds, which are known as natural antioxidants. Little is known about the fate of these compounds in the body once they are consumed, or where they do to influence health. This study aims to find out the contribution of phenolic compounds present in virgin olive oil to the prevention of diseases and promotion of health using new biomarker techniques (a biomarker is a small molecule acting as a ‘reporter’ for health and disease).

Who can participate?
Healthy adults, aged 18-75, who are not allergic to olive products.

What does the study involve?
Your body weight, height, waist circumference and blood pressure will be recorded and you will fill in a questionnaire to help us establish your intake of foods rich in phenolic compounds. During the 6-week study period, you will be randomly allocated to take a daily dose of olive oil (20 ml) with either a high or low polyphenolic content, to be consumed uncooked. At the beginning, middle and end of the study, participants will be asked to keep a record of the food eaten the day before the visit, to collect a ‘spot’ urine sample in a small tube (second urine of the day) and to provide a blood sample. We will measure, in urine and blood, the levels of small molecules (biomarkers) that are related to heart and kidney health, as well as the way food is digested, transformed in the body and excreted.

What are the possible benefits and risks of participating?
There are no benefits or risks associated with taking part in the trial.

Where is the study run from?
Not provided at time of registration.

When is the study starting and how long is it expected to run for?
The study started in July 2012 and ran for 6 weeks.

Who is funding the study?
University of Lisbon (Portugal).

Who is the main contact?
Dr William Mullen
william.mullen@glasgow.ac.uk

Contact information

Dr William Mullen
Scientific

Institute of Cardiovascular and Medical Sciences
Joseph Black Building
University of Glasgow
Glasgow
G12 8QQ
United Kingdom

Study information

Study designDouble-blind parallel supplementation study with low and high polyphenolic olive oil
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Patient information is available as a leaflet that can be obtained by contacting Dr Emilie Combet by telephone on 0141 201 0768 or via e-mail at emilie.combetaspray@glasgow.ac.uk, or Dr Bill Mullen on 0141 330 6210 (bill.mullen@glasgow.ac.uk). A third party who will be able to advise on the general research process is Professor Mike Lean (mike.lean@glasgow.ac.uk).
Scientific titleBioavailability of virgin olive oil bioactive compounds and impact of a 6-week supplementation on biomarkers of coronary artery disease, chronic kidney disease or diabetes
Study objectivesCan a 6-week supplemetation of olive oil with either a high or low polyphenolic content alter proteomic biomarkers of coronary artery disease, chronic kidney disease or diabetes?
Ethics approval(s)Ethics committee of the University of Glasgow, College of Medical, Veterinary and Life Sciences, 31/08/2012, ref. 2012071.
Health condition(s) or problem(s) studiedRisk of coronary artery disease, chronic kidney disease and diabetes
Intervention66 healthy volunteers will be randomly allocated into one of two groups and asked to consume 20 ml of olive oil per day for 6 weeks.

Group 1 will be given olive oil with a high polyphenolic content.
Group 2 will be given olive oil with a low polyphenolic content.

Blood and urine samples will be collected the day before the study starts and also after 3 weeks and at the end of the study. Blood pressure and weight will be recorded at these visits too.
Intervention typeOther
Primary outcome measureProteomic urinary biomarkers of coronary artery disease, chronic kidney disease and diabetes. These will be measured after 3 weeks, the mid point and after 6 weeks, the end of the study.
Secondary outcome measuresPlasma-based biomarkers of heart disease and blood pressure. These will be measured after 3 weeks, the mid point and after 6 weeks, the end of the study.
Overall study start date01/07/2012
Completion date31/08/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants66
Key inclusion criteriaHealthy adults, aged 18-75 years
Key exclusion criteria1. Those allergic to olive products
2. Currently taking medication (other than the contraceptive pill)
3. Have taken antibiotics in the last 3 months
4. Have received or are receiving treatments for any chronic gut disease
5. Is pregnant, trying to conceive, or lactating
Date of first enrolment01/07/2012
Date of final enrolment31/08/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Institute of Cardiovascular and Medical Sciences
Glasgow
G12 8QQ
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

c/o Dr WIlliam Mullen
Institute of Cardiovascular and Medical Sciences
Joseph Black Building
Glasgow
G12 8QQ
Scotland
United Kingdom

ROR logo "ROR" https://ror.org/00vtgdb53

Funders

Funder type

University/education

University of Lisbon, in collaboration with the Sovena company (Portugal)

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 01/01/2015 Yes No