Determination of glycemic response of Diabetes Specific Nutrition (DSN) Supplement in prediabetic adults.
Not Applicable
Completed
- Registration Number
- CTRI/2023/02/049511
- Lead Sponsor
- Hindustan Unilever Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 128
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
1)Subject having BMI <18.0 and >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method