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%)
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