Condition category
Circulatory System
Date applied
16/06/2009
Date assigned
28/07/2009
Last edited
17/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Anna Blasco

ORCID ID

Contact details

PRBB
IMIM-Hospital del Mar
URLEC
Dr. Aiguader
88
Barcelona
08003
Spain
ablasco@imim.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI04/1308

Study information

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

Acronym

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

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)

Study design

Parallel randomised controlled double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Olive oil (with/without phenolic content)

Primary outcome measures

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 trial start date

20/10/2007

Overall trial end date

20/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers aged 20 - 50 years old, either sex

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

90 volunteers (45 men and 45 women)

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

Trial participating centre

PRBB
Barcelona
08003
Spain

Sponsor information

Organisation

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

Sponsor details

C/Prim
12
Madrid
28004
Spain
info@pco.es

Sponsor type

Industry

Website

http://www.pco.es/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20179144

Publication citations

  1. Results

    Konstantinidou V, Covas MI, Muñoz-Aguayo D, Khymenets O, de la Torre R, Saez G, Tormos Mdel C, Toledo E, Marti A, Ruiz-Gutiérrez V, Ruiz Mendez MV, Fito M, In vivo nutrigenomic effects of virgin olive oil polyphenols within the frame of the Mediterranean diet: a randomized controlled trial., FASEB J., 2010, 24, 7, 2546-2557, doi: 10.1096/fj.09-148452.

Additional files

Editorial Notes