Impact of a Proprietary Standardized Olive Fruit Extract (SOFE) on Cardio-Ankle Vascular Index, Visual Analog Scale and C-Reactive Protein Assessments in Subjects with Arterial Stiffness Risk

Drugs R D. 2016 Dec;16(4):355-368. doi: 10.1007/s40268-016-0147-7.


Introduction: The chemical components of olive fruit provide a wide range of cardiovascular benefits. Arterial stiffness is an important cardiovascular risk factor and can be assessed using the Cardio-Ankle Vascular Index (CAVI).

Objective: The objective of this study was to assess the impact of a proprietary standardized olive fruit extract (SOFE) in subjects at risk for arterial stiffness.

Methods: Twelve of 36 subjects were assigned to each of the following groups for this 11-day, double-blind, placebo-controlled study: Group 1: 250 mg SOFE-50 mg active ingredient, hydroxytyrosol (dosage achieved with two capsules per day); Group 2: 500 mg SOFE-100 mg active ingredient, hydroxytyrosol (dosage achieved with two capsules per day); and Group 3: placebo.

Results: All three groups showed a decrease in CAVI scores, although no significant between-group differences were observed. Group 2 had the largest reduction, with mean CAVI scores decreasing from 11.02 to 8.91. Group 2 showed the strongest response in visual analog scale (VAS) energy intensity (11.71% increase). Results for C-reactive protein (CRP) blood levels showed no changes of statistical significance between groups. Mean triglyceride levels from Group 2 decreased by 21.64%, the most significant change among all three groups.

Conclusions: SOFE, an olive fruit extract containing many of the phytochemicals shown to provide cardiovascular benefits, was safe and well-tolerated. SOFE 500 mg had a greater effect on CAVI scores, suggesting improved arterial elasticity, and a clear reduction in triglycerides compared with placebo and SOFE 250 mg. The decreased CAVI scores suggest that increasing high-density lipoprotein cholesterol and lowering triglycerides with SOFE could potentially reduce patients' risk of developing atherosclerosis. Although more studies are needed, positive cardiovascular health trends, including improved vessel elasticity and positive triglyceride effects, were evident with SOFE.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Ankle Brachial Index*
  • C-Reactive Protein / antagonists & inhibitors*
  • C-Reactive Protein / metabolism
  • Cholesterol, HDL / metabolism
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Fruit / chemistry*
  • Humans
  • Middle Aged
  • Olea / chemistry*
  • Plant Extracts / administration & dosage
  • Plant Extracts / chemistry
  • Plant Extracts / pharmacology*
  • Risk Factors
  • Triglycerides / metabolism
  • Vascular Stiffness / drug effects*
  • Visual Analog Scale*


  • Cholesterol, HDL
  • Plant Extracts
  • Triglycerides
  • C-Reactive Protein