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