Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial

José C E Serrano, Eva Castro-Boqué, Alicia García-Carrasco, María Inés Morán-Valero, Daniel González-Hedström, Marcelino Bermúdez-López, José Manuel Valdivielso, Alberto E Espinel, Manuel Portero-Otín, José C E Serrano, Eva Castro-Boqué, Alicia García-Carrasco, María Inés Morán-Valero, Daniel González-Hedström, Marcelino Bermúdez-López, José Manuel Valdivielso, Alberto E Espinel, Manuel Portero-Otín

Abstract

The use of garlic (Allium sativum) for treating arterial hypertension has been recognized as effective for several decades. However, tolerance to treatment is low, and several technological modifications have been developed to improve its tolerability, such as the aging process at controlled temperature and humidity. This study aims to validate the antihypertensive effects of an optimized extract of aged black garlic with low doses of s-allyl-cysteine (SAC) in a Grade I hypertensive population with drug treatment. A randomized, triple-blind, placebo-controlled parallel trial was developed, where a daily supplementation with 0.25 mg/day of SAC for 12 weeks was performed. A reduction in systolic and diastolic blood pressure of 1.8 mmHg (0.7 to 4.1 95% CI) and 1.5 mmHg (0.3 to 3.0 95% CI), respectively, was observed. Similarly, an increase in blood nitric oxide (10.3 µM, 1.1 to 19.5 95% CI) and antioxidant capacity (7 × 10-3 µM TE/min, (1.2 to 13 × 10-3 95% CI) and a reduction in uric acid levels (-0.3 mg/dL, -0.5 to -0.001 95% CI) and ACE activity (-9.3 U/L; -18.4 to -0.4 95% CI) were observed. No changes in endothelial function and inflammatory cytokines were observed. It was concluded that low-dose SAC supplementation in an optimized black-garlic extract allows for an extra-significant reduction in blood pressure in a Grade I hypertensive population receiving drug treatment.

Keywords: aged black garlic; blood pressure; hypertension; s-allyl-cysteine.

Conflict of interest statement

A García-Carrasco, J.M. Valdivielso, and M. Portero-Otin do not declare any potential competing interests. Jose CE Serrano reports that Pharmactive Biotech Products S.L.U. provided financial support for study development. Maria Ines Moran Valero, Alberto E. Espinel, and Daniel Gonzalez Hedstrom report a relationship with Pharmactive Biotech Products SL that includes the employment of Pharmactive S.L., the company that produces and distributes the garlic extract used in this study.

Figures

Figure 1
Figure 1
Study and participants flowchart.
Figure 2
Figure 2
Daily changes in systolic blood pressure. Differences in the evolution of blood pressure were observed between Groups A and L (p = 0.0033 for the differences in slope). Group A (n = 38) did not show a linear regression (p = 0.3044), with a mean increase in systolic blood pressure of 6.7 × 10−3 mmHg/day after 12 weeks of treatment. Group L (n = 39) shows a good fit for a lineal regression (p = 0.0021), with a mean decrease in systolic blood pressure of 21.6 × 10−3 mmHg/day after 12 weeks of treatment.
Figure 3
Figure 3
Daily changes in diastolic blood pressure. Differences in the evolution of blood pressure were observed between Groups A and L (p = 0.0002 for the differences in slope). Group A (n = 38) did not show a linear regression (p = 0.2648), with a mean increase in diastolic blood pressure of 5.1 × 10−3 mmHg/day after 12 weeks of treatment. Group L (n = 39) shows a good fit for a lineal regression (p < 0.0001), with a mean decrease in diastolic blood pressure of 18.4 × 10−3 mmHg/day after 12 weeks of treatment.

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