The trial results, reported together in the Journal of the American Heart Association, show that adding a combination of three natural extracts to standard pharmacological treatments could help to fight hypertension and improve cardiovascular functions – especially in those whose blood pressure remains not well controlled.
Led by senior author Professor Carmine Vecchione, Dean of the Faculty of Medicine at Salerno University, the study investigated the potential of a novel nutraceutical formulation named AkP05 alongside standard medical treatment for hypertension that despite pharmaceutical intervention, remained uncontrolled.
“This is the first demonstration that supplementation with a novel nutraceutical combination can improve functional capacity and cardiovascular protection in uncontrolled hypertensive patients on antihypertensive medication,” wrote the team.
The nutraceutical formulation, known as AkP05, was supplied by Italian firm Damor Farmaceutic. The formulation is a blend of Bacopa Monnieri, Ginko biloba and green tea leaves, complexed with phosphatidylcholine.
“This novel nutraceutical combination is able to contribute to the reduction of blood pressure levels and to the improvement of endothelial function and exercise effort beyond classical pharmacological therapy,” said the authors.
The Italian research team investigated the effects of AkP05 through two separate trials in groups of hypertensive patients, all of them receiving standard therapies. The main characteristic of the selected patients was that, despite pharmacological treatments, their blood pressure remained not well controlled.
Selected patients, all of them receiving standard drug treatment, were divided into groups in order to test the efficacy of the plant extracts mix compared to placebo. A total of 69 uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in the two double‐blind studies.
In the first study, 45 participants were randomised to placebo or AkP05 – with blood pressure (BP), endothelial function, and circulating nitric oxide assessed before and at the end of 4 weeks of treatment.
Additionally, 24 patients were randomised to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems.
Results showed that AkP05 supplementation reduced blood pressure, improved endothelial function, and increased nitric oxide release, while the second trial cardiopulmonary exercise tests revealed that AkP05 increased maximum oxygen uptake, stress tolerance, and maximal power output.
"We saw that patients treated with this nutraceutical showed an improvement in crucial parameters such as oxygen consumption, strength, endurance to physical exercise,” said Dr Albino Carrizzo, first author of the publication. “These are indicators of a more efficient endothelial function.”
“Furthermore, cellular and animal models demonstrated that this effect is due to an increase of nitric oxide in the blood, an important element in vessels health,” he noted.
Vecchione and colleagues added that the magnitude of the improvements produced by AkP05 supplementation “suggests potential for the clinical management of hypertension.”
“Based on the efficacy revealed by our study, AkP05 might be considered as an adjunct for the treatment of hypertensive patients, improving both functional capacity and cardiovascular protection,” they said.
A new weapon
The Italian scientists noted that it is important to highlight that their results should not be seen as an alternative to standard hypertension therapies – rather as a further accompanying option.
"Hypertension is a very serious problem involving a growing part of the population and leading to serious pathologies,” noted Vecchione.
“Patients must be aware that pharmacological treatments play a fundamental role in the management of the problem,” she said. “If future researches will confirm our results, this new nutraceutical formulation will be a new weapon, accompanying standard therapies without replacing them".
The team added that their characterisation of beneficial cardiovascular properties from the combination of multiple naturally derived compounds could lay a foundation for the development of new, natural or nutritionally-based adjunct therapies aimed at improving cardiovascular protection and contributing to the achievement of target blood pressure levels.
“An interesting observation emerging from our research is that the four substances composing the mix have a hemodynamic action only when combined together, while they are ineffective when used individually,” said Carrizzo. “It is a real synergistic action".
Source: Journal of the American Heart Association
Published online, Open Access, doi: 10.1161/JAHA.119.014923
“New Nutraceutical Combination Reduces Blood Pressure and Improves Exercise Capacity in Hypertensive Patients Via a Nitric Oxide–Dependent Mechanism”
Authors: Albino Carrizzo, et al