The effects of lycopene on modulating oxidative stress and liver enzymes levels in metabolic syndrome patients: a randomised clinical trial

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