Novel Nutraceutical Compound Could Help Patients Control Their Hypertension

Albino Carrizzo, PhD

While “traditional” medicine draws reactions of ire or disgust from most clinicians, new data from a team of investigators in Italy has found a novel nutraceutical combination could have real benefits for patients with hypertension when added to standard treatment.

Results of proof-of-concept study suggest AkP05 (Izzek), which is a combination of Bacopa monnieri, a combination of extracts from of Ginkgo biloba and green tea leaves, and phosphatidylserine, could serve as an adjunct to benefit cardiovascular protection and help control high blood pressure in patients with difficulty managing their hypertension.

“We saw that patients treated with this nutraceutical showed an improvement in crucial parameters such as oxygen consumption, strength, endurance to physical exercise,” said lead investigator Albino Carrizzo, PhD, a researcher at I.R.C.C.S. Neuromed in Italy, in a statement. “These are indicators of a more efficient endothelial function.”

Based on the results of previous studies—including mouse and cellular models— indicating the use of AkP05 improved cognitive function and arterial compliance, investigators sought to determine the effect of the combination as an adjunct to standard therapy in patients with uncontrolled hypertension. With this in mind, 2 different 4-week studies were designed to compare AkP05 against either placebo or diuretic.

All patients included in the study were between the ages of 40 and 68 years old with unsatisfactory, but stable, blood pressure control and receiving pharmacologic therapy. In the first study, 45 patients were randomized in a 2:1 ratio to either AkP05 or placebo. In the second study, 24 patients were randomized 1:1 to either AkP05 or diuretic—investigators noted the second study was performed to rule out any possibility of interference from additional or different antihypertensive drugs.

Outcomes of interest in the first study were effect on blood pressure, endothelial function, and circulating nitrite oxide—these were assessed before and at the end of 4 weeks of treatment. In the second study, patients underwent a cardiopulmonary exercise test to assess the impact of AkP05 versus diuretic on the functional capacity of the cardiovascular, pulmonary, and muscular systems.

In the first study, investigators reported no statistically significant differences were found between the 2 groups and, at the end of treatment, no changes in systolic or diastolic blood pressure were observed in the placebo group. In the AkP05 group, 53.3% of the group achieved a blood pressure of 125/88 mm Hg or less compared to 6.66% of the placebo-treated group.

At the end of the second study, investigators noted significant improvements in systolic blood pressure in both treatment groups. Results also indicated an increase in maximum VO2 during exercise and a significant reduction in maximum systolic blood pressure was seen among patients in the AkP05.

Multiple limitations were noted by investigators—these were prefaced by investigators reaffirming their belief that AkP05 has cardiovascular effects. Limitations included small population size, being limited to a single site, failing to identify the active compounds released following digestion of AkP05, and lack of pharmacokinetic characterization.

This study, “New Nutraceutical Combination Reduces Blood Pressure and Improves Exercise Capacity in Hypertensive Patients Via a Nitric Oxide—Dependent Mechanism,” is published in the Journal of the American Heart Association.