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11 February 2012
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| [ Print-friendly version ] |
| The effect of phenolic content of olive oil on ischaemic reactive hyperaemia in pre-hypertensive subjects |
| ISRCTN | ISRCTN03450153 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of phenolic content of olive oil on ischaemic reactive hyperaemia in pre-hypertensive subjects |
| Scientific title | Effects of virgin olive oil enriched with phenolic compounds on blood pressure and endothelial function: a randomised double-blind crossover controlled trial |
| Acronym | OLIPA study |
| Serial number at source | N/A |
| Study hypothesis | Increased antioxidant capacity exerted by phenolic compounds improved endothelial function leading to reduced blood pressure in postprandial state. |
| Lay summary | |
| Ethics approval | Local medical ethics committee (Comité d'Ètica d'Investigació Clínica Hospital Universitari Sant Joan, Reus) approved on the 24th April 2008 (ref: 08-04-24/4proj5) |
| Study design | Randomised double-blind crossover controlled trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Ischaemic reactive hyperaemia/blood pressure |
| Participants - inclusion criteria |
1. 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 |
| Participants - exclusion criteria |
1. 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 |
| Anticipated start date | 28/01/2009 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 30 (15 men and 15 women) |
| Interventions |
All 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. |
| Primary outcome measure(s) |
1. 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 measure(s) |
Difference 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 |
| Sources of funding | Spanish Ministry of Education and Science (Spain) (ref: AGL2005-07881-C02-01/ALI) |
| Trial website | |
| Publications | |
| Contact name | Prof Rosa Sola |
| Address | C/ Sant Llorenç, 21 |
| City/town | Reus |
| Zip/Postcode | 43201 |
| Country | Spain |
| Sponsor | Rovira i Virgili University (Spain) |
| Address |
Health Science Faculty
C/ Sant Llorenç, 21 |
| City/town | Reus |
| Zip/Postcode | 43201 |
| Country | Spain |
| Sponsor website: | http://www.urv.net/ |
| Date applied | 18/01/2010 |
| Last edited | 02/02/2010 |
| Date ISRCTN assigned | 02/02/2010 |
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