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Molecular mechanisms involved in the protective role of olive oil in the development of atherosclerotic processes

Molecular mechanisms involved in the protective role of olive oil in the development of atherosclerotic processes: a parallel randomised controlled double-blind clinical trial with three arms of dietary intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53283428
Enrollment
90
Registered
2009-07-28
Start date
2007-10-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular risk Circulatory System Cardiovascular risk

Interventions

Volunteers were grouped randomly into three groups (n = 30 each one) to receive during 3 months the following treatments: 1. Traditional Mediterranean diet with virgin olive oil (TMD+VOO) 2. Traditio

Sponsors

Spanish Olive Oil Producers Association (Patrimonio Comunal Olivarero) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers aged 20 - 50 years old, either sex

Exclusion criteria

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 30 kg/m^2) 6. Hypercholestrolaemia greater than 8.0 mmol per litre or dyslipidaemia therapy indication 7. Diabetes 8. Hypertension (systolic blood pressure [SBP] greater than 140 mmHg, diastolic blood pressure [DBP] greater than 90 mmHg) 9. Multiple allergies 10. Coeliac or other intestinal diseases 11. Any condition that limits the mobility of the subject making study visits impossible 12. Life-threatening illnesses such as cancer or a severe disease with a less than 3-year expectancy 13. Other diseases or conditions that could worsen adherence to the measurements or treatments 14. Vegetarians and people following special diets 15. Alcoholism or other drug addiction

Design outcomes

Primary

MeasureTime frame
Gene expression changes related to cardiovascular risk, measured at baseline and after 3 months of intervention. Blood samples were collected from 8.00 to 10.00 a.m. at fasting state. Spot morning urine samples were collected.

Secondary

MeasureTime frame
Oxidative stress and Inflammation, measured at baseline and after 3 months of intervention. Blood samples were collected from 8.00 to 10.00 a.m. at fasting state. Spot morning urine samples were collected.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026