Effect of SophorOx® on Oxidative Stress and Body Composition in Individuals with High BMI: A Randomized Controlled Trial

Purpose: The study aimed to investigate the efficacy and safety of SophorOx (R) (LN-OS-22) on oxidative stress and body composition in adults with excessive body weight and obesity. Participants and Methods: The 56-days randomized, double-blind, placebo-controlled, parallel-group, multi-centric clinical trial had individuals aged 30-60 years with body mass index (BMI) >= 25 to <= 34.9 kg/m(2). 68 participants were randomly allocated to LN-OS-22 or placebo groups. The primary outcome was improvement in the oxidative stress. Secondary outcomes were changes in plasma lipopolysaccharide (LPS) and serum malondialdehyde (MDA) levels, weight and waist circumference, inflammatory markers, and quality of life. Results: At day 56, a statistically significant change in the 8-Isoprostane levels between LN-OS-22 vs placebo was observed (p = 0.0222). As compared to placebo, at the end of study, statistically significant reductions were demonstrated in body weight, waist circumference and BMI in the LN-OS-22 group (p < 0.0001). Also, a statistically significant change when compared to placebo for the energy/stamina domain (p = 0.0300) of the Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) questionnaire was depicted in LN-OS-22 group. Conclusion: The study demonstrates that LN-OS-22 was effective in reducing the oxidative stress, anthropometrics and improving the quality of life in individuals with overweight and obesity.