Efficacy and Safety of an Oral Nutritional Supplement for Diabetes and Obesity in Pregnancy: A Phase 3 Randomized Controlled Trial

Efficacy and Safety of an Oral Nutritional Supplement for Diabetes and Obesity in Pregnancy: A Phase 3 Randomized Controlled Trial

Reedhika Puliani1, Deepika Sharma2, Priyanka Shetty Sridhar3

1Nutritionist, British Biologicals, Bengaluru, India

 2Pharmacist, Prakhar Group, Gondia, India

 3Global Sales & Marketing Head, British Biologicals, Bengaluru, India

Abstract:

Gestational Diabetes Mellitus (GDM) and obesity are one of the most common complications during pregnancy, contributing to significant risks in the mother and foetus. Indicated by carbohydrate intolerance, GDM can lead to complications for the mother and the foetus. Nutritional supplements with nutrients such as myo-inositol, omega-3 fatty acids, vitamin D, zinc, iron and folic acid can help in managing GDM and obesity, while preventing nutritional deficiencies during pregnancy. This multicentre, Double blind, Randomized comparative, Parallel Group, Placebo controlled Phase III Clinical trial evaluated the efficacy and safety of a nutritional supplement from British Biologicals Pvt Ltd, Pro PL Lite (Chocolate flavour) against a placebo powder in pregnant women with GDM and obesity. Over 6 weeks, 231 participants were recruited, with 200 completing the study. Results demonstrated that Pro-PL Lite achieved 99% and 98% efficacy in managing obesity and GDM, respectively, while showing optimal safety and tolerability. These findings support the use of the product for managing GDM and obesity in pregnant women.

Keywords: Gestational Diabetes Mellitus, Diabetes, Supplements, Health, Diet