Efficacy of a Diabetes Specific Nutrition Supplement on Glycemic, Anthropometric, Dietary and Gut Health Markers in Adults with Type 2 Diabetes: An RCT

Abstract

With increasing incidence of diabetes, use of diabetes specific nutrition supplements (DSNS) is common for better management of the disease. To study effect of 12-week DSNS supplementation on glycemic markers, anthropometry, lipid profile, SCFAs, and gut microbiome in individuals with diabetes. Markers studied were glycemic [Fasting Blood Glucose (FBG), Post Prandial Glucose (PPG), HbA1c, Incremental Area under curve (iAUC), Mean Amplitude of Glycemic Excursions (MAGE), Time in/above Range (TIR/TAR)], anthropometry [weight, Body Mass Index (BMI), waist circumference (WC)], lipid profile, diet and gut health [plasma short chain fatty acids (SCFAs)]. N = 210 adults were randomized to receive either DSNS with standard care (DSNS + SC; n = 105) or standard care alone (SC alone; n = 105). After 12 weeks, significant differences between DSNS + SC versus SC alone was observed in FBG [−3 ± 6 vs 14 ± 6 mg/dl; p = 0.03], PPG [−35 ± 9 vs −3 ± 9 mg/dl; p = 0.01], weight [−0.6 ± 0.1 vs 0.2 ± 0.1 kg; p = 0.0001], BMI [−0.3 ± 0.1 vs 0.1 ± 0.1 kg/m 2 ; p = 0.0001] and WC [−0.3 ± 0.2 vs 0.2 ± 0.2 cm; p = 0.01]. HbA1C and low-density lipoprotein (LDL) were significantly reduced in DSNS + SC [−0.2 ± 0.9; p = 0.04 and −5 mg/dl; p = 0.03] respectively with no change in control. Continuous Glucose Monitoring (CGM) reported significant differences between DSNS + SC versus SC alone for mean glucose [−12 ± 65 vs 28 ± 93 mg/dl; p < 0.01], TAR 180 [−9 ± 42 vs 7 ± 45 mg/dl; p = 0.04], TAR 250 [−3 ± 27 vs 9 ± 38 mg/dl; p = 0.05], iAUC [−192 (1.1) vs −48 (1.1) mg/dl; p = 0.03]. MAGE was significantly reduced for both DSNS + SC (−19 ± 67; p < 0.001) and SC alone (−8 ± 70; p = 0.04), with reduction being more pronounced for DSNS + SC. DSNS + SC reported a decrease in carbohydrate energy % [−9.4 (−11.3, −7.6) %; p < 0.0001] and amount [−47.4 (−67.1, −27.7) g; p < 0.0001], increased dietary fiber [9.5 (7.2, 11.8) g; p < 0.0001] and protein energy % [0.9 (0.5, 1.3) %; p < 0.0001] versus SC alone. DSNS + SC reported significant increases versus SC alone in total (0.3 ng/ml; p = 0.03) and individual plasma SCFAs. The consumption of DSNS significantly improves the glycemic, anthropometric, dietary, and gut health markers in diabetes.