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

Not provided at time of registration

Contact information

Ms Anna Blasco
Scientific

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

Email	ablasco@imim.es

Study information

Study design	Parallel randomised controlled double-blind clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	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
Study hypothesis	A 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)
Condition	Cardiovascular risk
Intervention	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. 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 type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Olive oil (with/without phenolic content)
Primary outcome measure	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 outcome measures	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.
Overall study start date	20/10/2007
Overall study end date	20/10/2008

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	90 volunteers (45 men and 45 women)
Participant inclusion criteria	Healthy volunteers aged 20 - 50 years old, either sex
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 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
Recruitment start date	20/10/2007
Recruitment end date	20/10/2008

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

Email	info@pco.es
Website	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 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

Study outputs

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