A prospective, parallel group, interventional and open label study to evaluate the effect of probiotics on glycemic control in pre-diabetic patients

Abstract

Background: Prediabetes represents an intermediate metabolic state characterized by impaired glucose tolerance and a high risk of progression to diabetes. With rising global burden of diabetes, early interventions are essential. Emerging evidence suggests that gut microbiota plays a significant role in metabolism and probiotics may offer a novel and safe therapeutic approach. Methods: This prospective, parallel-group, interventional and open-label study was conducted on 70 prediabetic patients. Participants were divided into two groups: Group A received a probiotic capsule containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii (2.5 billion CFU) once daily along with diet control as per American Diabetes Association recommendations, while Group B was advised only diet control for 90 days. Fasting Plasma Glucose (FPG), 2-Hour Plasma Glucose (2HPG) and HbA1c were assessed as primary objectives along with Total cholesterol, LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), Serum Triglycerides, Body weight and BMI as secondary objectives. Safety was evaluated through monitoring of adverse events. Results: Probiotic supplementation along with diet control resulted in statistically significant reduction in mean FPG (p=0.018) within group A. There was a statistically non-significant difference in change in FPG (p=0.28), 2HPG (p=0.48) and HbA1c (p=0.17) between group A and B. Statistically significant difference was seen in reduction in mean Total cholesterol (p=0.01), LDL-C (p=0.009), body weight (p=0.03) and BMI (p=0.03), increase in mean HDL - C (p=0.006) and a statistically non-significant difference in change in mean Triglyceride (p=0.17) levels between group A and B. The intervention was well tolerated, with minimal and non-serious adverse events reported. Conclusions: Probiotic supplementation did not provide a significant additional benefit over diet control in improving glycemic parameters in prediabetic patients. However, it resulted in significant improvement in lipid profile, body weight and BMI. Both interventions were well tolerated with comparable safety profiles.