The effect of phenolic content of olive oil on ischaemic reactive hyperaemia in pre-hypertensive subjects

ISRCTN ISRCTN03450153
DOI https://doi.org/10.1186/ISRCTN03450153
Secondary identifying numbers N/A
Submission date
18/01/2010
Registration date
02/02/2010
Last edited
26/08/2014
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

Prof Rosa Sola
Scientific

C/ Sant Llorenç, 21
Reus
43201
Spain

Study information

Study designRandomised double-blind crossover controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of virgin olive oil enriched with phenolic compounds on blood pressure and endothelial function: a randomised double-blind crossover controlled trial
Study acronymOLIPA study
Study objectivesIncreased antioxidant capacity exerted by phenolic compounds improved endothelial function leading to reduced blood pressure in postprandial state.
Ethics approval(s)Local medical ethics committee (Comité d'Ètica d'Investigació Clínica Hospital Universitari Sant Joan, Reus) approved, 24/04/2008, ref: 08-04-24/4proj5
Health condition(s) or problem(s) studiedIschaemic reactive hyperaemia/blood pressure
InterventionAll participants will follow a stabilisation period of 1 week with a low saturated fat diet. The day before to the postprandial test was followed by a polyphenol-free diet. Participants will be randomised individually between two postprandial tests:
1. Virgin olive oil. This will have a polyphenol content of 332.63 mg/kg (or 332.63 ppm measured by HPLC-DAD), an amount similar to oils in the area.
2. Virgin olive oil enriched with polyphenols. This will be enriched with polyphenols from defatted olive paste, which increase the concentrations up to three times, reaching a total content of 1008.14 mg/kg (or 1008.14 ppm measured by HPLC-DAD). These oils are prepared by the research group from Universitat de Lleida.

Participants will be provided with 80 g of bread containing 30 ml of the oil they have been allocated to. For 300 minutes after ingestion, participants will rest and may only drink water. One week later, participants will take the other investigational product in the same manner as before.

Diet monitoring will be conducted through a 3-day dietary record, in weeks 1 and 2. Participants are advised to maintain their usual physical activity and are monitored by a physical activity questionnaire.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Virgin olive oil enriched with phenolic compounds
Primary outcome measure1. Blood pressure, measured at baseline and 120, 240 and 300 minutes on each study day
2. Endothelial function and activation biomarkers, measured at baseline and 120 , 240 and 300 minutes on each study day
Secondary outcome measuresDifference between the two oils (from baseline to 120, 240 and 300 minutes) of the following parameters:
1. The concentration of phenolic compounds in plasma, up to 300 minutes
2. Lipoproteins (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, triglycerides) and apolipoproteins A1 and B100
3. Liver function tests
4. Angiotensin converting enzymes (ACE) inhibitory activity
5. Biomarkers of oxidation (LDL oxidised lipoperoxides, 8-epi-prostaglandin F2)
6. Biomarkers of inflammation (interleukin 6, high sensitivity C-reactive protein [hsCRP])
7. Antithrombotic activity biomarkers (plasminogen activator inhibitor-1 [PAI-1], factor VII antigen [FVIIag], activated factor VII [FVIIa])
8. Endothelial activation biomarkers (vascular cell adhesion molecules [VCAMs], intercellular adhesion molecules [ICAMs], e-selectin)
9. The relationship between nitrate (NO3)/nitrite (NO2)
10. Glycaemia and insulin resistance by Homeostatic Model Assessment (HOMA) index
11. The genetic profile of genes involved in endothelial function and blood pressure
Overall study start date28/01/2009
Completion date31/03/2010

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 (15 men and 15 women)
Key inclusion criteria1. Healthy volunteers aged 18 to 75 years, either sex
2. Systolic blood pressure levels upper or equal 120 to 159 mmHg and/or diastolic blood pressure upper or equal 80 to 99 mmHg without antihypertensive treatment
Key exclusion criteria1. Low density lipoprotein cholesterol (LDL-c) levels upper 189 mg/dL
2. Triglycerides upper 350 mg/dL (the threshold level to determine LDL-c by the Friedewald formula)
3. Chronic alcoholism
4. Body mass index (BMI) upper 30 kg/m^2
5. Statin treatment prior to initiating the trial and would not have left at least 2 months before starting the study
6. Antihypertensive treatment prior to initiating the trial and would not have left at least 2 months before starting the study
7. Having diabetes mellitus (if you develop a blood glucose, fasting, upper 126 mg/dL, should be repeated and confirmed)
8. Renal disease (plasma creatinine levels upper 1.4 mg/dL for women and upper 1.5 mg/dL for men
9. Having acute infectious diseases, malignancies, severe liver insufficiency, chronic respiratory insufficiency or associated endocrine diseases
10. Other conditions such as special nutritional requirements or medications that may affect lipid metabolism or blood pressure
11. Participate or participating in a clinical trial in the last 3 months
12. Incapacity to continue in the study
13. History of gastrointestinal disease that can impair the absorption of nutrients
14. Suicide attempt
Date of first enrolment28/01/2009
Date of final enrolment31/03/2010

Locations

Countries of recruitment

  • Spain

Study participating centre

C/ Sant Llorenç, 21
Reus
43201
Spain

Sponsor information

Rovira i Virgili University (Spain)
University/education

Health Science Faculty
C/ Sant Llorenç, 21
Reus
43201
Spain

Website http://www.urv.net/
ROR logo "ROR" https://ror.org/00g5sqv46

Funders

Funder type

Government

Spanish Ministry of Education and Science (Spain) (ref: AGL2005-07881-C02-01/ALI)

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 15/01/2015 Yes No