Rachana Bhoite, Anitha Chandrasekaran, Shivani Aacharya, Amey Mane, Suyog Mehta, Ravindra Machhindra Kale, Gayathri Nagamuthu, Sasikala Selvaraj, Gayathri Rajagopal, Sudha Vasudevan, Anjana Ranjit Mohan, Ranjit Unnikrishnan, Kamala Krishnaswamy, Mohan Viswanathan
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.