The trial enrolled 87 participants at three hospitals in India: 44 received SlimSEB® and 43 received maltodextrin placebo. Participants were 30 to 65 years old and all were Asian. The cohort included 43 people classified as overweight, with a body-mass index of 26–29.9 kg/m², and 44 classified as obese, with a BMI of at least 30 kg/m². Eligibility required fasting glucose of 6.1–7.0 mmol/L. The protocol also excluded people with type 2 diabetes using a threshold of at least 7.0 mmol/L, creating an overlap at the 7.0 mmol/L boundary that complicates interpretation of that criterion.

Participants took two capsules twice daily, 15–20 minutes before afternoon and evening meals, for 84 consecutive days. SlimSEB® contained 1.5 billion colony-forming units of five probiotic strains, a mixture of digestive enzymes, and 95.5 mg of additional ingredients: mulberry-leaf extract, green tea, cinnamon powder and chromium picolinate. Placebo capsules contained maltodextrin and matched the investigational product in packaging, appearance, size, weight, color and labeling. Block randomization with a block size of six, independent sequence generation and coded batch numbers were used to conceal allocation, while participants, clinicians, investigators and other trial personnel remained blinded until completion of the clinical phase.

Body weight was the main focus, but investigators also measured BMI, waist circumference, fasting plasma glucose, fasting insulin, glycated hemoglobin, calculated insulin-resistance indices, blood lipids and C-reactive protein. They compared change from baseline using unadjusted tests and an ANCOVA model adjusted for variables including diet, physical activity, visit and treatment interactions, with baseline score included as a covariate. Analyses used 95% confidence intervals and a two-sided significance threshold of 5%. All 87 randomized participants completed the 84-day intervention and the two-week washout follow-up, making the intention-to-treat and per-protocol populations identical.

Among participants classified as overweight, the average weight change with SlimSEB® was a loss of 2.4 ± 4.0 kg, compared with a loss of 0.1 ± 2.9 kg among placebo recipients. The adjusted least-squares mean difference was −2.60 kg, with a 95% confidence interval of −4.343 to −0.851 kg and p = 0.0045. Among participants with obesity, the supplement group lost 3.6 ± 1.7 kg while the placebo group gained 0.9 ± 3.6 kg; the adjusted difference was −4.51 kg, with a 95% confidence interval of −5.984 to −3.031 kg and p < 0.0001. The reported reductions corresponded to 3.2% in the overweight group and about 4.2–4.3% in the obese group.

BMI and waist circumference followed the same broad pattern. In overweight participants, BMI fell by 0.9 ± 1.5 kg/m² with SlimSEB®, versus 0.1 ± 1.2 kg/m² with placebo, producing an adjusted difference of −0.92 kg/m² and p = 0.0063. Among participants with obesity, BMI fell by 1.4 ± 0.7 kg/m² with the supplement while rising by 0.4 ± 1.4 kg/m² with placebo; the adjusted difference was −1.8 kg/m², with a 95% confidence interval of −2.389 to −1.22 kg/m². Waist circumference declined by 4.7 ± 6.6 cm in overweight supplement users and 5.6 ± 7.4 cm in obese users. Adjusted differences versus placebo were −3.86 cm and −11.03 cm, respectively, although the unadjusted comparison in the overweight subgroup did not reach conventional statistical significance.

Several glucose-related measures also favored the supplement, although results varied by weight category and analytical method. Adjusted differences in fasting plasma glucose were −0.45 mmol/L in overweight participants and −0.45 mmol/L in participants with obesity. Glycated hemoglobin fell by 1.2 ± 0.8 percentage points in the overweight supplement group and 1.3 ± 1.1 points in the obese supplement group, compared with decreases of 0.6 ± 1.2 and 0.4 ± 0.8 points with placebo. Adjusted between-group differences were −0.65 and −0.67 percentage points. HOMA-IR, a calculated measure of insulin resistance, fell by 0.79 ± 0.57 in overweight users and 0.92 ± 0.74 in obese users, with adjusted differences of −0.47 and −0.69. Differences in fasting insulin, HOMA-beta, disposition index and QUICKI were less consistent between groups.

Blood cholesterol produced some of the clearest contrasts, particularly among participants with obesity. Total cholesterol in the supplement group fell by 32 ± 40 mg/dL, while it rose by 16 ± 22 mg/dL with placebo; the adjusted between-group difference was −38.09 mg/dL and p < 0.0001. LDL cholesterol declined by 18 ± 34 mg/dL in obese supplement users and increased by 15 ± 23 mg/dL with placebo, yielding an adjusted difference of −24.04 mg/dL and p = 0.0002. Among overweight participants, adjusted total-cholesterol and LDL differences were −20.54 and −14.86 mg/dL, respectively. HDL and triglyceride changes did not yield consistently significant between-group differences. C-reactive protein fell by 13.6% in overweight and 17.3% in obese supplement users; the adjusted difference was significant in the obese subgroup but not the overweight subgroup.

Safety outcomes were reassuring during treatment and the two-week follow-up. Eight mild adverse events were recorded in six participants receiving SlimSEB®: one case each of a cold, cough, fever and headache in the overweight subgroup, and two cases each of dry cough and headache in the obese subgroup. Investigators judged none of the events to be related to SlimSEB®, and all resolved after concomitant treatment. No serious adverse events occurred, and nobody discontinued because of an adverse event. The investigators characterized use of emergency or rescue treatment as negligible. Most participants rated tolerability as very good, while one overweight participant rated it good. Hematological and biochemical measures, including blood counts, liver enzymes, creatinine, blood urea nitrogen, albumin and globulin, remained within reference ranges overall.

The findings remain preliminary because treatment lasted only 84 days, follow-up extended just 14 days beyond the intervention, and the sample was too small to assess uncommon adverse events or establish long-term efficacy. Diet and physical activity were not monitored or controlled, despite both being important determinants of weight and metabolic measures. Because SlimSEB® combines several active ingredients, the trial cannot determine whether probiotics, enzymes, herbal extracts, chromium or another component produced the changes or establish a mechanism of action. The authors call for larger trials with longer intervention periods. For now, the randomized comparison supports a short-term association between SlimSEB® and reduced weight and selected metabolic risk markers in the studied population, rather than proof that the supplement treats obesity, prevents type 2 diabetes or improves cardiovascular outcomes.

Subject of Research: Randomized trial of a probiotic, enzyme and herbal supplement for weight and metabolic outcomes in adults at risk of type 2 diabetes.

Article Title: 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

Article References: Rathi, A., Muley, A. B., & Rathi, V. L. (2026). 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. Frontiers in Nutrition, 13, Article 1956865. https://doi.org/10.3389/fnut.2026.1956865

Image Credits: AI Generated

DOI: 10.3389/fnut.2026.1956865

Keywords: SlimSEB, weight management, randomized clinical trial, type 2 diabetes risk, obesity, probiotics, digestive enzymes, insulin resistance, cholesterol, glycemic control, Assessment, efficacy