The Effects of Lycopene on Modulating Oxidative Stress and Liver Enzymes Levels in Metabolic Syndrome Patients: A Randomised Clinical Trial

The pathogenesis of metabolic syndrome (MetS) complications involves the excessive production ofreactive oxygen species, inflammation, and endothelial dysfunction. Due to Lycopene, a highly unstable structure andits significant effects on modulating the metabolic system, there is a strong need for a formula that can increase itsstability. The aim of this study was to develop an approach for encapsulating Lycopene and investigate its effects oninflammatory markers, oxidative stress, and liver enzymes in patients with MetS. This study is a simple randomized, double-blind, objective-based clinical trial that involvedeighty subjects with MetS, who were equally and randomly assigned to two groups: one group received 20 mg ofLycopene per day for 8 weeks, and the Placebo group followed the same protocol as the Lycopene group but receiveda placebo instead of Lycopene. They were called Lycopene and placebo, respectively. During follow-up visits after 4and 8 weeks, 20 ml of blood was collected for evaluation of liver enzymes and some inflammatory related markers. Prior to the assignment of volunteers to their respective groups, there were no notable differences in C-reactiveprotein (CRP), serum liver enzymes, systolic and diastolic blood pressure, or pro-oxidant-antioxidant balance (PAB)between the Lycopene and placebo groups. However, our subsequent analysis revealed a significant reduction in theserum levels of CRP (P=0.001) and PAB (P=0.004) in the group that received Lycopene. Our encapsulated Lycopenetreatment was not associated with a significant difference in serum levels of alanine aminotransferase (ALT), aspartatetransferase (AST), or alkaline phosphatase (ALP) between our two groups. This study investigated the impact of Lycopene on individuals with MetS, revealing a noteworthymodulation effect on PAB and inflammation linked to MetS. However, no significant differences was demonstrated inserum levels of ALT, AST and ALP between the studied group (registration number: IRCT20130507013263N3).