Glycemic Index of a Diabetes-Specific Nutritional Powder: An Open-Label Study in Healthy Indian Adults

Abstract

Background: A balanced diet with a low glycemic index (GI) plays an important role in controlling and managing type 2 diabetes mellitus (T2DM). Here, we compared the GI of 2 flavors (vanilla and chocolate) of diabetes-specific nutritional (DSN) supplements to its comparator in healthy Indian adults under fasting conditions. Methods: This study was a 39-day open-label, non-comparative, single-center trial involving healthy adults aged between 18 to 45 years. The subjects received equal doses of 2 DSN powder (Treatments A and B), the comparator product (Treatment C), and dextrose monohydrate as a reference (Treatment R). Doses were administered as per the dosing schedule, after an overnight fast for 10 hours, with 2 intervening non-dosing days. Blood samples were collected on the dosing days to assess changes in capillary blood glucose levels. The primary endpoint of the study was the mean GI of Treatments A, B, and C (Defined as low: GI ≤ 55; medium: 55 GI ≤ 70; High: GI > 70), generated using the incremental area under the curve (AUCi) methodology. Safety was assessed throughout the study. Values of all study parameters were represented in ±SD or standard deviation. Results: Fourteen adult male subjects with a mean age of 29.42 ± 4.46 years, and a body mass index of 22.0 ± 1.95 Kg/m2, were enrolled in the study. The mean AUCi for treatments A, B, and C were 104 ± 10, 111 ± 12, and 87 ± 12 mmol min/L, respectively and for Treatment R it was 276 ± 16, 319 ± 28 and 338 ± 25 mmol min/L for Days 1, 6 and 8, respectively. The mean GI of Treatment A was 33 ± 3, Treatment B was 35 ± 3 and Treatment C was 29 ± 5; all GI means were ≤55. Mild adverse events were reported in 2 (14.3%) subjects. No serious adverse events or deaths were reported in the study. All treatments were well tolerated by the subjects. Conclusion: The glycemic index of both test products and comparator was low (i.e., GI 55) as per ISO 26642:2010 standard.