Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/12/2005
Date assigned
06/01/2006
Last edited
03/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kepka.org/eurolive

Contact information

Type

Scientific

Primary contact

Dr María Isabel Covas

ORCID ID

Contact details

Lipids and cardiovascular Epidemiology Unit
Institut Municipal d´Investigació Mèdica (IMIM)
Carrer Dr. Aiguader
80
Barcelona
08003
Spain
+34 (0)932257571
mcovas@imim.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

QLK1-CT-2001-00287

Study information

Scientific title

The effect of olive oil on oxidative damage in European populations

Acronym

EUROLIVE

Study hypothesis

Olive oil consumption will provide benefits on oxidative damage. These benefits will increase with the phenolic content of the olive oil.

Ethics approval

Not provided at time of registration

Study design

Randomised crossover controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Oxidative damage to lipids and Deoxyribonucleic Acid (DNA)

Secondary outcome measures

Lipids and lipoprotein metabolism

Overall trial start date

20/09/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy, non-smoking, voluntary men aged 20 - 60 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

180 participants from 6 Centres of 5 European countries

Participant 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

Recruitment start date

20/09/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

Spain

Trial participating centre

Institut Municipal d´Investigació Mèdica (IMIM)
Barcelona
08003
Spain

Sponsor information

Organisation

European Commission, Research Directorate

Sponsor details

Rue de la Loi 200
Brussel
B-1049
Belgium
+32 (0)2 296 18 65
callum.searle@cec.eu.int

Sponsor type

Other

Website

http://www.cordis.lu

Funders

Funder type

Government

Funder name

European Commission (Belgium) (ref: QLK1-CT-2001-00287)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16954359
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22440854
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26136585

Publication citations

  1. Results

    Covas MI, Nyyssönen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Bäumler H, Nascetti S, Salonen JT, Fitó M, Virtanen J, Marrugat J, , The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial., Ann. Intern. Med., 2006, 145, 5, 333-341.

  2. Results

    Castañer O, Covas MI, Khymenets O, Nyyssonen K, Konstantinidou V, Zunft HF, de la Torre R, Muñoz-Aguayo D, Vila J, Fitó M, Protection of LDL from oxidation by olive oil polyphenols is associated with a downregulation of CD40-ligand expression and its downstream products in vivo in humans., Am. J. Clin. Nutr., 2012, 95, 5, 1238-1244, doi: 10.3945/ajcn.111.029207.

  3. Results

    Hernáez Á, Remaley AT, Farràs M, Fernández-Castillejo S, Subirana I, Schröder H, Fernández-Mampel M, Muñoz-Aguayo D, Sampson M, Solà R, Farré M, de la Torre R, López-Sabater MC, Nyyssönen K, Zunft HF, Covas MI, Fitó M, Olive Oil Polyphenols Decrease LDL Concentrations and LDL Atherogenicity in Men in a Randomized Controlled Trial, J Nutr, 2015.

Additional files

Editorial Notes