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

Effects of virgin olive oil enriched with phenolic compounds on blood pressure and endothelial function: a randomised double-blind crossover controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03450153
Enrollment
30
Registered
2010-02-02
Start date
2009-01-28
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic reactive hyperaemia/blood pressure Circulatory System Other acute ischaemic heart diseases

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 random

Sponsors

Rovira i Virgili University (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026