The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial

Martiné Wlosinska, Ann-Christin Nilsson, Joanna Hlebowicz, Anders Hauggaard, Maria Kjellin, Mohammed Fakhro, Sandra Lindstedt, Martiné Wlosinska, Ann-Christin Nilsson, Joanna Hlebowicz, Anders Hauggaard, Maria Kjellin, Mohammed Fakhro, Sandra Lindstedt

Abstract

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).

Keywords: Aged garlic extract; Blood pressure; CRISP-DM; Calcium score; Data mining; Data science; Double-blinded; Placebo-controlled.

Conflict of interest statement

Dr. Lindstedt has received a research grant to support this research from Wakunaga of America Ltd. None of the other authors has conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
CONSORT statement (consolidated standards of reporting trials) flow chart. Showing demographics and baseline clinical information of the study cohort. Aged garlic extract (AGE), coronary artery calcification (CAC)

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