The effect of olive oil on oxidative damage in European populations

ISRCTN	ISRCTN09220811
DOI	https://doi.org/10.1186/ISRCTN09220811
Protocol serial number	QLK1-CT-2001-00287
Sponsor	European Commission, Research Directorate
Funder	European Commission (Belgium) (ref: QLK1-CT-2001-00287)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr María Isabel Covas
Scientific

Lipids and cardiovascular Epidemiology Unit
Institut Municipal d´Investigació Mèdica (IMIM)
Carrer Dr. Aiguader, 80
Barcelona
08003
Spain

Phone	+34 (0)932257571
Email	mcovas@imim.es

Primary study design	Interventional
Study design	Randomised crossover controlled trial
Secondary study design	Randomised cross over trial
Scientific title	The effect of olive oil on oxidative damage in European populations
Study acronym	EUROLIVE
Study objectives	Olive oil consumption will provide benefits on oxidative damage. These benefits will increase with the phenolic content of the olive oil.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oxidative damage to lipids
Intervention	Three types of olive oil with differences in their phenolic content (25 ml per day). Intervention periods of three weeks separated by two week-washout periods.
Intervention type	Other
Primary outcome measure(s)	Oxidative damage to lipids and Deoxyribonucleic Acid (DNA)
Key secondary outcome measure(s)	Lipids and lipoprotein metabolism
Completion date	30/06/2003

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target sample size at registration	180
Key inclusion criteria	Healthy, non-smoking, voluntary men aged 20 - 60 years
Key exclusion criteria	1. Intake of antioxidant supplements 2. Intake of acetosalicylic acid 3. Intake of any other drug with established antioxidative properties 4. Athletes with high physical activity (greater than 3000 kcal per week in leisure-time physical activity) 5. Obesity (Body Mass Index [BMI] greater than 32 kg per m^2) 6. Hypercholestrolemia greater than 8.0 mmol per litre or dyslipemia therapy indication 7. Diabetes 8. Multiple allergies 9. Celiac or other intestinal diseases 10. Any condition that limits the mobility of the subject making study visits impossible 11. Life threatening illnesses such as cancer or a severe disease with a less than 3-year expectancy 12. Other diseases or conditions that could worsen adherence to the measurements or treatments 13. Vegetarians and people following special diets
Date of first enrolment	20/09/2002
Date of final enrolment	30/06/2003

Institut Municipal d´Investigació Mèdica (IMIM)

Barcelona
08003
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/09/2006		Yes	No
Results article	results	01/05/2012		Yes	No
Results article	results	01/08/2015		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes