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

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.

SUBMITTER: Serrano JCE

PROVIDER: S-EPMC10490347 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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

Serrano José C E JCE Castro-Boqué Eva E García-Carrasco Alicia A Morán-Valero María Inés MI González-Hedström Daniel D Bermúdez-López Marcelino M Valdivielso José Manuel JM Espinel Alberto E AE Portero-Otín Manuel M

Nutrients 20230823 17

The use of garlic (<i>Allium sativum</i>) 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 popul ...[more]

PMID: 37686723

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Project description:BACKGROUND:One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP-DM). METHOD:This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score???10 after CT scan (n?=?104) were randomized to an intake of placebo or AGE (2400?mg daily) for 1?year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers. RESULT:104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p?<?0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and IL-6 (OR 2.56 [1.00-6.53]) in favor of the active group. There was also a significant (p?=?0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0?months, to 140 (SD: 15) mmHg after 12?months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group. CONCLUSIONS:AGE inhibits CAC progression, lowers IL-6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE. TRIAL REGISTRATION:Clinical trials NCT03860350, retrospectively registered (1/32019).

Project description:Arterial stiffness is a cardiovascular risk factor that increases with age. Kyolic aged garlic extract has been shown to reduce arterial stiffness, while normalizing blood pressure, cholesterol and blood thickness. The present study hypothesized that increased flexibility of arteries could lead to slower blood flow and increased oxygen uptake and overall aerobic fitness. The present 12 week trial aimed to assess the effect of Kyolic aged garlic extract (AGE) on arterial stiffness, aerobic fitness, lactate threshold, recovery from muscle soreness and cardiovascular proteomic biomarkers in middle-aged (40-65 years) endurance athletes with elevated arterial stiffness. A total of 75 middle-aged recreational endurance athletes completed the trial, after being randomly allocated for 12 weeks to either the placebo or Kyolic aged garlic extract groups: low-dose cohort 1 (n=37), 2 capsules/day containing 1.2 g AGE powder and 1.2 mg S-allylcysteine (SAC); and the high-dose cohort 2 (n=38), 4 capsules/day of 2.4 g AGE powder and 2.4 mg SAC. Arterial stiffness was assessed through pulse wave velocity measurements and aerobic fitness was measured by volume-maximal-oxygen-consumption (VO2max) and lactate thresholds during high-intensity exercise using a cycle-ergometer-test-station, as well as measuring the levels of muscle fatigue and recovery time at 12 weeks compared with the baseline results. Urinary proteomic analysis was performed in a subgroup of participants and measured the levels of certain relevant proteins used as biomarkers for risk of cardiovascular events, at 12 weeks compared with baseline results. The Kyolic aged garlic extract group significantly improved their aerobic fitness, as was evidenced by increased VO2max, increased aerobic power, higher lactate threshold-to-oxygen uptake, higher lactate threshold-to-power output and quicker recovery times compared with the placebo group. Pulse wave velocity, a measure for arterial flexibility, was improved in the Kyolic aged garlic extract group compared with the placebo. The proteomics analysis demonstrated that a subset of polypeptides associated with cardiovascular risk, such as heart attacks and stroke, decreased in the Kyolic aged garlic extract group at 12 weeks compared with the baseline, which was contrary to the effects observed in the placebo group. Therefore, the results of the present study suggested that Kyolic aged garlic extract significantly improved aerobic fitness, lactate threshold, recovery and cardiovascular proteomic biomarkers in middle-aged endurance athletes within 12 weeks. The present clinical trial was registered on 11/03/2020 at the Australian New Zealand Clinical Trial Registry (trial registration no. ACTRN12620000340932).

Project description:Several previous studies have demonstrated that aged garlic extract (AGE) inhibits the progression of coronary artery calcification and non-calcified plaque (NCP) in the general population. However, its effects on plaque progression in patients with diabetes have not yet been investigated, at least to the best of our knowledge. This study investigated whether AGE reduces the coronary plaque volume measured by cardiac computed tomography angiography (CCTA) in patients with diabetes mellitus (DM). A total of 80 participants with DM with a median age of 57 years were prospectively assigned to consume 2,400 mg AGE/day (after completion, 37 participants) or placebo (after completion, 29 participants) orally. Both groups underwent CCTA at baseline and follow-up 365 days apart. In total, 66 participants completed the study. Coronary plaque volume, including total plaque (TP), dense calcium (DC), fibrous, fibro-fatty and low-attenuation plaque (LAP) volumes were measured based upon pre-defined intensity cut-off values using semi-automated software (QAngio CT). Changes in various plaque types were normalized to the total coronary artery length. The non-parametric Wilcoxon rank-sum test was performed to examine the differences in plaque formation between the 2 groups. No significant differences were found in the baseline characteristics between the AGE and placebo groups. Compared with the placebo group, the AGE group exhibited a statistically significant regression in normalized LAP [median and standard deviation (SD) -0.2 (18.8) vs. 2.5 (69.3), P=0.0415]. No differences were observed in TP, fibrous, or fibrofatty plaque volumes between the AGE and placebo group. On the whole, this study indicated that the %LAP change in the AGE group was significantly greater than that in the placebo group in patients with diabetes. However, further studies are warranted to evaluate whether AGE has the ability to stabilize vulnerable plaque and decrease adverse cardiovascular events.

Dataset Information

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

Publications

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

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