Efficacy and Safety of Armolipid Plus^®: An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials

• Main Authors: Arrigo F. G. Cicero, Cormac Kennedy, Tamara Knežević, Marilisa Bove, Coralie M. G. Georges, Agnė Šatrauskienė, Peter P. Toth, Federica Fogacci
• Format: Article
• Language: English
• Published: MDPI AG 2021-02-01
• Series: Nutrients
• Subjects: Armolipid Plus^®; red yeast rice; berberine; nutraceutical; supplementation; lipids
• Online Access: https://www.mdpi.com/2072-6643/13/2/638

Armolipid Plus^® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus^® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus^®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus^® exerted a significant effect on body mass index (mean difference (MD) = −0.25 kg/m², <i>p</i> = 0.008) and serum levels of total cholesterol (MD = −25.07 mg/dL, <i>p</i> < 0.001), triglycerides (MD = −11.47 mg/dL, <i>p</i> < 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, <i>p</i> < 0.001), low-density lipoprotein cholesterol (MD = −26.67 mg/dL, <i>p</i> < 0.001), high sensitivity C reactive protein (hs-CRP, MD = −0.61 mg/L, <i>p</i> = 0.022), and fasting glucose (MD = −3.52 mg/dL, <i>p</i> < 0.001). Armolipid Plus^® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus^® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.