Assessment of efficacy and safety of SlimSEB® for weight reduction in overweight and obese subjects at risk of type 2 diabetes mellitus: a prospective, randomized, double-blind, parallel-group, controlled, interventional clinical study

Objective The current clinical study intended to explore the clinical efficacy and safety of SlimSEB ® for weight reduction in overweight and obese subjects with the risk of type 2 diabetes mellitus. Methodology Eighty-seven subjects (43 overweight and 44 obese) were enrolled in this prospective, interventional, randomized, double-blind, parallel, controlled, clinical study. Subjects were randomized for daily administration of SlimSEB ® or placebo for 84 days. The change in anthropometric parameters (body weight, BMI and waist circumference), glucose and insulin related factors (fasting plasma glucose, fasting insulin, hemoglobin A1c, homeostatic model assessment for insulin resistance, homeostasis model assessment of β-cell function, disposition index, and quantitative insulin sensitivity check index), and lipid profile and biomarkers (total cholesterol, LDL, HDL, triglycerides, and CRP) were assessed. Additional outcomes included changes in visual analogue scale and tolerance to SlimSEB ®, and the incidences of adverse events (AEs) and serious adverse events (SAEs). Results The oral supplementation of SlimSEB ® was associated with greater reductions in anthropometric, glycemic, lipid and metabolic parameters than placebo. The body weight, BMI and waist circumference showed significantly greater reductions with SlimSEB® than placebo, with adjusted least square mean differences of −2.60 kg and −4.51 kg ( p = 0.0045, p < 0.0001), −0.92 kg/m² and −1.80 kg/m² ( p = 0.0063, p < 0.0001), and −3.86 cm and −11.03 cm ( p = 0.0169, p = 0.0014) in overweight and obese subjects, respectively. Significant adjusted improvements were also observed with SlimSEB ® for fasting plasma glucose (−0.45 mmol/L, −0.45 mmol/L; p = 0.0124 and p = 0.0068), HbA1c (−0.65% and −0.67%; p = 0.0199 and p = 0.003), HOMA-IR (−0.47, −0.69; p = 0.0205 and p = 0.002) in overweight and obese subjects. The lipid parameter analyses showed significant adjusted reductions in total cholesterol by 14.21 and 16% with SlimSEB ® in overweight and obese subjects, compared with 3.85% reduction and 8.65% increase in placebo ( p = 0.0089 and p < 0.0006). The LDL cholesterol also decreased in overweight and obese subjects by 11.61 and 14.63% over 0.88% reduction and 13.39% increase in placebo ( p = 0.0154 and p = 0.0002). CRP levels decreased by 13.6 and 17.3% with SlimSEB ® in overweight and obese subjects, respectively, with a significant inter-group difference in obese subjects ( p = 0.0001). SlimSEB ® was well tolerated at the studied dose, with eight mild AEs reported, none of which was considered related to SlimSEB ®, and no SAEs were reported. Conclusion Daily intake of SlimSEB ® resulted in a reduction in body weight, BMI and waist circumference, and showed beneficial changes in selected glucose and lipid parameters, and promote a healthy inflammatory response. These findings suggest that SlimSEB ® may support weight management and metabolic health. Further well-designed clinical trials involving larger study populations and longer intervention periods are needed to understand the underlying mechanisms of action. Clinical trial registration The current investigation was registered in the Clinical Trial Registry, India (CTRI registration number: CTRI/2023/11/059798), and registered on 14/11/2023 ( https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=OTM3Mjk=&Enc=&userName= ).