A Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Herbal Extract and Micronutrient Blend Supplementation in People with Prediabetes

Abstract

Background and Objective: Prediabetes is a precursor stage to type 2 diabetes mellitus (T2DM), characterized by elevated blood glucose levels. This study aimed to evaluate the efficacy and safety of herbal extract and micronutrient blend supplementation in managing prediabetes. Materials and Methods: This multicentric, randomized, placebo-controlled study involved 319 subjects with prediabetes (159 in the test group and 160 in the placebo group). Considering the dropouts, a total of 303 patients were analyzed. The test group received herbal extract and a micronutrient blend, while the placebo group received a placebo for 90 days along with lifestyle modifications. Anthropometric parameters, glycemic markers (glycated hemoglobin [HbA1c], fasting and postprandial plasma glucose, and homeostatic model assessment for insulin resistance [HOMA-IR]), lipid profile, perceived stress, and health-related quality of life (HRQoL) were assessed. Results: Compared to the placebo group, the test group exhibited significant improvements in anthropometric parameters (weight, body mass index, and body fat percentage), lipid profile, glycemic control (reduced HbA1c by 6.9%, fasting plasma glucose by 15.4%, postprandial plasma glucose by 8.9%, and HOMA-IR by 19.7%), perceived stress reduction, and enhanced HRQoL (P < 0.001). The intervention was well-tolerated, with no clinically significant changes in lipid profiles, hematological parameters, or vital signs. Conclusion: Herbal extract and micronutrient blend supplementation effectively improved glycemic control, anthropometric parameters, and overall well-being in people with prediabetes, potentially reducing the risk of progression to T2DM.