Effect of High-Protein High-Fibre Supplement on Glycaemic Control in Overweight and Obese Indian Adults with Type 2 Diabetes Mellitus: A 24-Week, Randomized, Controlled Trial

Background: Foods rich in protein, dietary fibre and low in glycaemic index could potentially improve glycaemic control and help in management of type 2 diabetes mellitus (T2DM) in overweight/obese participants. In this study, the effect of high-protein high-fibre (HPHF) nutritional supplement in addition to standard medical care for glycaemic control was evaluated. Methods: In this open-label, parallel-arm, randomised study, 100 overweight/obese participants with T2DM (aged 30-65 years) were randomised (1:1) to either intervention group (25 g HPHF nutritional supplement [twice daily]+standard care of T2DM) or a control group (standard care of T2DM), for 6 months. Primary endpoint included change from baseline in 24��?hour glycaemic response at weeks 12 and 24. Results: Of 320 participants screened, 100 participants were randomised to either the intervention group (n=50) or the control group (n=50). In the intervention group; the mean (SE) daily incremental area under curve (IAUC) from baseline to week 24 was significantly lower ��?23.0 mg-15min/dL (57.2) compared to control group 168.0 mg-15min/ dL (39.0), p=0.008. The intervention group showed significant reduction in glycosylated haemoglobin (HbA1c) (p=0.03) and fasting blood sugar (p=0.01) level at the end of week 24 compared to the control group. Conclusions: Twice-daily consumption of HPHF nutritional supplement (25 g each) significantly improved glycaemic control, reduced the average 24-hour glycaemic response and postprandial glucose spikes. Inclusion of HPHF supplement would be a useful effective aid to glycaemic control in overweight/obese participants with T2DM.