Following in the footsteps of the Mediterranean diet, an olive leaf extract has been found to support cardiovascular health, reports Frutarom
Ever since it was discovered that the incidence of heart attack is much lower across the Mediterranean than in other regions, the positive effects of the Mediterranean diet, and of olives in particular, have been of great interest. The unsaturated fatty acids and antioxidant compounds such as the polyphenol oleuropein can provide protection against cardiovascular disease. However, few people realise that this health-promoting substance is found in higher concentrations in the leaves of the olive tree too. Benolea, an olive leave extract from Frutarom, has been shown in clinical trials and in vivo studies to support the cardiovascular system and a healthy heart.
Cardiovascular diseases (CVDs) are the main cause of death globally. According to the World Health Organization (WHO), an estimated 17.5 million people died from CVDs in 2012.1 Two of the main risk factors for CVD are hypertension and elevated cholesterol. Hypertension already affects one billion people worldwide and more than one third of the adult population has raised total cholesterol levels.2,3 Although some risk factors (age, family history) cannot be modified, others such as high cholesterol, hypertension and diabetes can be prevented or decreased, resulting in an enormous CVD risk reduction. A 10% drop in serum cholesterol in men aged 40 has been reported to result in a 50% reduction in heart disease within 5 years.4
The first line of defence against CVD is to adopt a healthy lifestyle, starting with a balanced diet coupled with increased physical activity. The Mediterranean diet, with its abundant use of olive oil, is the gold standard for healthy nutrition and associated with a reduced risk for CVDs.5 Initially, the benefits were attributed to the high intake of monounsaturated fatty acids (MUFAs); but, in recent years, particular attention has been focused on the beneficial properties of the ‘minor’ olive components such as oleuropein and other polyphenols.
These key components are also contained in the olive leaf, in even greater concentration. Oleuropein not only has potent antioxidant and anti-inflammatory properties, it also boasts hypoglycaemic, antihypertensive and antiatherosclerotic effects.6,7
With Benolea, Frutarom has developed an extract, supported by scientific data and published studies, that show it can support the reduction of risk factors associated with CVDs, such as high blood pressure and raised blood lipids. Benolea is manufactured according to a multicomponent system philosophy that sees the whole of a plant’s raw material as active, rather than just its fractions or isolates. Similar to other Frutarom extracts, Benolea is manufactured using the EFLA HyperPure patent, guaranteeing easy handling and high purity, as well as a unique market positioning.
Benolea is standardised on two key constituents: oleuropein and polyphenols. In synergy with other components of the multicomponent system, oleuropein is a chemical compound with proven blood-pressure lowering effects. To ensure the high antioxidant activity that supports cardiovascular health, Benolea is also standardised on polyphenol content.
The beneficial effects on cardiovascular health that have been demonstrated in preclinical studies have also been confirmed in clinical studies during the last few years. In the latest clinical study, Benolea showed a comparable blood pressure reducing effect in people with mildly elevated values (stage 1 hypertension) than a standard antihypertensive drug, Captopril.8 Benolea also positively influenced the lipid profile of this population, was safe and well tolerated.
This randomised, double-blind, double-dummy, active-controlled clinical trial involved 232 volunteers aged 25 to 60 with stage 1 hypertension (systolic blood pressure of 140–159mmHg and/or diastolic blood pressure of 90–99mmHg) who were not taking any medication or were asked to stop it upon consent. A 4-week run-in period without treatment was followed by 8 weeks of treatment with either one 500mg Benolea tablet twice a day or one 12.5mg Captopril tablet twice a day. After 2 weeks, if participants showed no response to Captopril, they received a double dose. Dietary advice was given to help participants manage their hypertension, and adverse events and changes in laboratory parameters (routine hematology, serum electrolytes, liver and renal function) were monitored.
The blood pressure reduction in the Benolea group after 8 weeks amounted to about 12 mmHg for systolic and 5 mmHg for diastolic blood pressure, respectively (Figure 1). Additionally, this study also investigated the effect on blood lipids of the olive leaf extract in such patients. Benolea significantly reduced total cholesterol (Figure 2) and triglyceride levels. Such positive effects were not observed in the Captopril group.
Figure 1: Benolea resulted in a reduction of systolic blood pressure that was effectively comparable with that exerted by Captopril, as shown in the latest clinical study with mild hypertensive volunteers
These findings echo the results of a preliminary study in twins, which was conducted in Germany.9 Monozygotic twins with borderline hypertension (blood pressures between 120/80 and 160/95) received a daily dosage of 500 and 1000mg of Benolea in tablet form for 8 weeks. Results confirmed a dose-dependent blood pressure lowering effect, with maximum values of 13mmHg systolic and 5mmHg diastolic blood pressure (Figure 3). These numbers are relevant considering that accumulated data from trials indicate that a sustained reduction of 6mmHg in diastolic blood pressure reduces the risk of stroke by about 40%.9
Figure 2: Benolea reduced total cholesterol values in the latest clinical study
The study also proved there was an additional benefit, namely a significant LDL (Low Density Lipoprotein) cholesterol reduction (Figure 4). Increased levels of LDL are associated with atherosclerosis and, consequently, heart attack, stroke and peripheral vascular disease. For this reason, LDL cholesterol is often called ‘bad’ cholesterol.
Benolea yielded a dose-dependent reduction in blood pressure with time in the twin study
Also in this study, tolerance of the extract was extremely high, with no evidence of side-effects. The results from these clinical studies confirm the findings of the in vivo study with rats, which demonstrated a dose dependent curative and preventive blood pressure lowering effect.10 Another additional effect of Benolea is the blood sugar lowering effect confirmed by in vivo findings (unpublished data). Benolea ameliorated glucose tolerance after ingestion of a starch solution compared with controls. The antioxidant activity of Benolea was shown to exceed that of vitamin C (unpublished data) in the ORAC test – a standard test for the determination of antioxidant capacity.
Figure 4: Benolea resulted in a significant decrease in LDL cholesterol in the twin study
The dual effect of Benolea — reducing blood pressure and improving the lipid profile — is advantageous: lower levels are a target for reducing the risk for cardiovascular diseases. Its additional antioxidative properties also contribute as eating a diet rich in antioxidant-containing foods, such as fruits, vegetables and whole grains, decreases this risk and therefore promotes cardiovascular health.
On the basis of such solid scientific data, Benolea enables manufacturers to offer products with proven beneficial effects on heart health. The product is stable in film-coated tablets and is clearly water-soluble. It can be used in still or carbonated drinks in appropriate dosages, in consideration with food regulatory laws that may apply.
Thanks to its heart health promoting properties and its excellent tolerance, Benolea can be seen as a valuable ingredient in a healthy diet. With the prevalence of CVDs rising across the globe, this represents a huge opportunity for manufacturers of dietary supplements and functional foods to offer clinically supported products to a rapidly growing population group.
5. E. Ros, et al., 'Mediterranean Diet and Cardiovascular Health: Teachings of the PREDIMED Study,' Advances in Nutrition 5, 335S–336S (2012).
6. B. Barbaro, et al., 'Effects of the Olive-Derived Polyphenol Oleuropein on Human Health,' International Journal of Molecular Sciences 15(10), 18508–18524 (2014).
7. M. de Bock, et al., 'Olive (Olea europaea L.) Leaf Polyphenols Improve Insulin Sensitivity in Middle-Aged Overweight Men: A Randomized, Placebo-Controlled, Crossover Trial,' PLoS One 8(3), e57622 (2013).
8. E. Susalit, et al., 'Olive (Olea europaea) Leaf Extract Effective in Patients with Stage-1 Hypertension: Comparison with Captopril,' Phytomedicine 18, 251–258 (2011).
9. T.Perrinjaquet-Moccetti, et al., 'Food Supplementation with an Olive (Olea europaea L.) Leaf Extract Reduces Blood Pressure in Borderline Hypertensive Monocygotic Twins,' Phytotherapy Research 22, 1239–1242 (2008).
10. M.T. Khayyal, et al., 'Blood Pressure Lowering Effect of an Olive Leaf Extract (Olea europaea) in l-NAME-Induced Hypertension in Rats,' Arzneimittelforschung 52(11), 797–802 (2002).