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The effect of olive oil on oxidative damage in European populations
DOI 10.1186/ISRCTN09220811
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of olive oil on oxidative damage in European populations
Scientific title
Serial number at source QLK1-CT-2001-00287
Study hypothesis Olive oil consumption will provide benefits on oxidative damage. These benefits will increase with the phenolic content of the olive oil.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised, crossover, controlled trial
Countries of recruitment Spain
Disease/condition/study domain Oxidative damage to lipids
Participants - inclusion criteria Healthy, non-smoking, voluntary men aged 20 - 60 years
Participants - 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
Anticipated start date 20/09/2002
Anticipated end date 30/06/2003
Status of trial Completed
Patient information material
Target number of participants 180 participants from 6 Centres of 5 European countries
Interventions 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.
Primary outcome measure(s) Oxidative damage to lipids and Deoxyribonucleic Acid (DNA)
Secondary outcome measure(s) Lipids and lipoprotein metabolism
Sources of funding European Commission (Belgium) (ref: QLK1-CT-2001-00287)
Trial website http://www.kepka.org/eurolive
Publications 2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16954359
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22440854
Contact name Dr  María Isabel  Covas
  Address Lipids and cardiovascular Epidemiology Unit
Institut Municipal d´Investigació Mèdica (IMIM)
Carrer Dr. Aiguader, 80
  City/town Barcelona
  Zip/Postcode 08003
  Country Spain
  Tel +34 (0)932257571
  Fax +34 (0)932257550
  Email mcovas@imim.es
Sponsor European Commission, Research Directorate
  Address Rue de la Loi 200
  City/town Brussel
  Zip/Postcode B-1049
  Country Belgium
  Tel +32 (0)2 296 18 65
  Fax +32 (0)2 2960540
  Email callum.searle@cec.eu.int
  Sponsor website: http://www.cordis.lu
Date applied 08/12/2005
Last edited 14/07/2014
Date ISRCTN assigned 06/01/2006
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