A Double Blind, Randomised, Four Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Collagen Peptide as a Nutraceutical Therapy in the Management of Type II Diabetes Mellitus

Abstract

Dipeptidyl peptidase-4 (DPP-4) inhibitors constitute an innovative class of oral agents for the treatment of Type 2 Diabetes Mellitus (T2DM). DPP-4 inhibitors increase glucagon-like peptide-1 (GLP-1) availability and correct the “incretin defect” seen in T2DM patients. Peptides derived from collagen have been reported to have DPP-4 inhibitory properties. A double blind randomized trial has been conducted to evaluate the effectiveness of Collagen peptides (CPT) as nutritional supplement in subjects with T2DM. Resistant dextrin (RD), a non-digestible dietary polymer, has been used as active comparator in this study. The clinical study was conducted over a total duration of 12 weeks of treatment period. The study was conducted on 66 enrolled subjects randomized in a 2:2:1:1 ratio as a four arm clinical study design. The subjects consumed either CPT (2.5/5 g) or resistant dextrin (2.5/5 g) for 90 days. The results showed that the consumption of 5 g CPT resulted in significant reduction in fasting blood glucose (FBG) and Glycosylated Haemoglobin (HbA1c) in three months study period in subjects. Insulin sensitivity measured in as HOMA IR has also been improved significantly in the group. Thus this study demonstrates the potential role of CPT as add on nutritional supplement for the management of T2DM.