The effect of olive oil on oxidative damage in European populations

ISRCTN	ISRCTN09220811
DOI	https://doi.org/10.1186/ISRCTN09220811
Secondary identifying numbers	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

Study design	Randomised crossover controlled trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Not specified
Study type	Treatment
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	Oxidative damage to lipids and Deoxyribonucleic Acid (DNA)
Secondary outcome measures	Lipids and lipoprotein metabolism
Overall study start date	20/09/2002
Completion date	30/06/2003

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	180 participants from 6 Centres of 5 European countries
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

European Commission, Research Directorate
Other

Rue de la Loi 200
Brussel
B-1049
Belgium

Government

European Commission (Belgium) (ref: QLK1-CT-2001-00287)
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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