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
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
-
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.