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

ISRCTN ISRCTN53283428
DOI https://doi.org/10.1186/ISRCTN53283428
Secondary identifying numbers PI04/1308
Submission date
16/06/2009
Registration date
28/07/2009
Last edited
17/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Anna Blasco
Scientific

PRBB
IMIM-Hospital del Mar
URLEC
Dr. Aiguader, 88
Barcelona
08003
Spain

ablasco@imim.es

Study information

Study designParallel randomised controlled double-blind clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMolecular 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
Study objectivesA traditional Mediterranean diet will modulate the expression of protective genes related with atherosclerosis processes. Virgin olive oil rich in phenolic compounds will provide further benefits.
Ethics approval(s)The local medical ethics committee (Comitè Ètic d'Investigació Clínica de l'Institut Municipal d'Assistència Sanitària [CEIC-IMAS]) approved on the 13th September 2004 (ref: 2004/1827/I)
Health condition(s) or problem(s) studiedCardiovascular risk
InterventionVolunteers 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. Traditional Mediterranean diet with washed virgin olive oil (TMD+WOO)
3. Habitual diet

For obtaining the washed virgin olive oil, the virgin olive used for the Group 1 treatment was washed by a procedure developed in the Instituto de la Grasa, Sevilla, Spain. This washed virgin olive oil maintained the same characteristics as group 1's virgin olive oil with the exception of the phenolic content which was not present. Olive oils were provided to the subjects of both groups 1 and 2 in sufficient amount for the entire family (15 L/per volunteer) during the intervention period of for cooking and raw purposes. Volunteers were assessed by the nutritionist to maintain their habitual lifestyle (i.e, physical activity, etc). Volunteers of groups 1 and 2 received intensive nutritional advice by trained nutritionists concerning the traditional Mediterranean diet pattern. At the end of the intervention, volunteers compliance was evaluated by values of tyrosol and hydroxytyrosol, the major virgin olive oil phenolic compounds in their first morning spot urine samples.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Olive oil (with/without phenolic content)
Primary outcome measureGene 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 outcome measuresOxidative 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.
Overall study start date20/10/2007
Completion date20/10/2008

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants90 volunteers (45 men and 45 women)
Key inclusion criteriaHealthy volunteers aged 20 - 50 years old, either sex
Key exclusion criteria1. 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
Date of first enrolment20/10/2007
Date of final enrolment20/10/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

PRBB
Barcelona
08003
Spain

Sponsor information

Spanish Olive Oil Producers Association (Patrimonio Comunal Olivarero) (Spain)
Industry

C/Prim, 12
Madrid
28004
Spain

info@pco.es
http://www.pco.es/

Funders

Funder type

Hospital/treatment centre

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Fondo de Investigacion Sanitaria (FIS-FEDER)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 Yes No
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