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Aged garlic extract preserves cutaneous microcirculation in patients with increased risk for cardiovascular diseases: A double-blinded placebo-controlled study.

ABSTRACT: Laser Doppler velocimetry estimates tissue perfusion providing a record of microvascular blood flow. Patients with heart disease or diabetes mellitus have impaired microvascular perfusion leading to impaired wound healing. Aged garlic extract (AGE) has a positive effect on vascular elasticity. This study aimed to assess the effect of long-term treatment with AGE on cutaneous tissue perfusion. A total of 122 patients with Framingham Risk Score ≥ 10 were randomised in a double-blinded manner to placebo or 2400 mg AGE daily for 1 year and monitored. Cutaneous microcirculation was measured at 0 and 12 months using laser Doppler velocimetry. A repeated measures analysis of variance (ANOVA) with a Greenhouse-Geisser correction determined that mean post-occlusive reactive hyperaemia differed significantly between time points. The mean percent change between the two time points 0 and 12 months was 102, 64 (174, 15)% change for AGE and 78, 62 (107, 92)% change for the placebo group (F[1, 120] = 5. 95, P < 0.016), 12 months of AGE increases the microcirculation in patients with an increased risk for cardiovascular events estimated using the Framingham risk score. Increased microcirculation could hypothetically facilitate wound healing.

SUBMITTER: Wlosinska M

PROVIDER: S-EPMC7949022 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Aged garlic extract preserves cutaneous microcirculation in patients with increased risk for cardiovascular diseases: A double-blinded placebo-controlled study.

Wlosinska Martine M Nilsson Ann-Christin AC Hlebowicz Joanna J Malmsjö Malin M Fakhro Mohammed M Lindstedt Sandra S

International wound journal 20190913 6

Laser Doppler velocimetry estimates tissue perfusion providing a record of microvascular blood flow. Patients with heart disease or diabetes mellitus have impaired microvascular perfusion leading to impaired wound healing. Aged garlic extract (AGE) has a positive effect on vascular elasticity. This study aimed to assess the effect of long-term treatment with AGE on cutaneous tissue perfusion. A total of 122 patients with Framingham Risk Score ≥ 10 were randomised in a double-blinded manner to pl ...[more]

PMID: 31518044

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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.

Project description:BackgroundMigraine is a common and distressing neurological condition characterised by recurrent throbbing headaches, nausea and heightened sensitivity to light and sound. Accumulating evidence suggests that cerebral arteries dilate during migraine, causing distal microvessels to constrict, which could activate nociceptors and cause onset of headache pain. If so, preventing or attenuating chronic microvascular constriction, and promoting a dilatory phenotype, may reduce frequency and/or severity of migraines. The primary aim of the L-Arginine and Aged Garlic Extract (LARGE) trial is to investigate whether oral treatment with dietary nutraceuticals, L-arginine and aged garlic extract (AGE), both systemic vasodilatory agents, will alleviate migraine frequency, duration and severity in adults with chronic frequent episodic migraines.MethodsThe study is a randomised double-blind placebo-controlled phase-II single-site clinical trial conducted in Perth, Australia. The target sample is to recruit 240 participants diagnosed with chronic frequent episodic migraines between 18 and 80 years of age. Participants will be randomised to one of four treatment groups for 14 weeks (placebo induction for 2 weeks, followed by 12 weeks on one of the respective treatment arms): placebo, L-arginine, AGE, or a combination of L-arginine and AGE. The doses of L-arginine and AGE are 1.5 g and 1 g daily, respectively. The primary outcome is to assess migraine response using change in migraine frequency and intensity between baseline and 12 weeks. Secondary outcomes include the impact of L-arginine and/or AGE on photosensitivity, retinal vessel changes, and blood biomarker concentrations of vascular tone, following a 12-week intervention.DiscussionThe protocol describes the oral administration of 2 nutraceutical-based interventions as possible prophylactic treatments for chronic frequent episodic migraines, with potential for direct clinical translation of outcomes. Potential limitations of the study include the fixed-dose design of each treatment arm and that in vivo neuroimaging methods, such as magnetic resonance imaging (MRI), will not be conducted to determine putative cerebro-vasodilatory changes to coincide with the outcome measures. Dose-response studies may be indicated.Trial registrationThe trial was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12621001476820 (Universal Trial Number: U1111-1268-1117) on 04/08/2021. This is protocol version 1, submitted on 25/11/2022.

Dataset Information

Aged garlic extract preserves cutaneous microcirculation in patients with increased risk for cardiovascular diseases: A double-blinded placebo-controlled study.

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Aged garlic extract preserves cutaneous microcirculation in patients with increased risk for cardiovascular diseases: A double-blinded placebo-controlled study.

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