None listed
Conditions
Interventions
Intervention1: DSN Supplement: 60g quantity in 250 ml of double toned milk, 4 visits, single dose.
30 g each time in 200 ml warm water, twice in a day (once before breakfast and one time between lunch
Sponsors
Hindustan Unilever Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 30 to 65 years (both inclusive) at the time of consent 2) Sex: Male and non-pregnant/non-lactating female. 3) Prediabetic subject having HbA1C = 5.7% and = 6.4%.
Exclusion criteria
Exclusion criteria: 1) Subject having BMI 32.5 kg/m2. 2) Subject having any acute infections like viral fever, typhoid, cold, diarrhea, constipation in the last 1 month. 3) Subject having any eating disorder or lactose intolerance. 4) Subject taking any herbal/Ayurvedic/traditional preparation/nutrition supplements that could profoundly affect blood glucose. 5) Pregnant and lactating women. 6) Subject planning to relocate in the next 1 month. 7) Subject planning longer duration of travel out of town during study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of DSN supplement and lifestyle counselling versus lifestyle counselling alone on glycemic response in prediabetic adults, as measured by incremental area under the curve (iAUC).Timepoint: Day 1, Day 15, Day 29 and Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on fasting plasma glucose (FPG) in adults with prediabetes.Timepoint: Day 1, Day 15, Day 29 and Day 43;To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on glycemic variability (GV) percentage.Timepoint: Day 1 to Day 14 Day 29 to Day 42 ;To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on mean amplitude of glycemic excursions (MAGE).Timepoint: Day 1 to Day 14 Day 29 to Day 42;To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on mean glucose levels in adults with prediabetes.Timepoint: Day 1 to Day 14 Day 29 to Day 42 ;To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on percentage change in Time in Range (TIR).Timepoint: Day 1 to Day 14 Day 29 to Day 42;To determine the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone through calculating change in e-HbA1C.Timepoint: Day 1 to Day 14 Day 29 to Day 42;To observe the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on change in anthropometric measures such as weight, BMI, waist circumferenceTimepoint: Day 0 and Day 42;To observe the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on change in blood pressure.Timepoint: Day 0 and Day 42;To observe the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on change in body fat percentage.Timepoint: Day 0 and Day 42;To observe the effect of DSN supplement and lifestyle counselling versus lifestyle counselling alone on change in skeletal mass.Timepoint: Day 0 and Day 42 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed