None listed
Conditions
Interventions
Intervention1: Nutritional powder with 25g of available CHO: (1) The nutritional product equivalent to 25g of available carbohydrate will be weighed and added to appropriate volume of water and admini
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and/or Female subject with the age group 18 to 60 years. 2.The subject should be overweight/ obese with a Body mass index (BMI) in the range of 23-33 kg/m2 (Asian Indian specific cut offs) 3. The subject should be willing to refrain from smoking, alcohol and caffeine containing drinks during the study period. 4. The subject should be willing to comply with study protocol requirements including adherence to diet and lifestyle modifications. 5. The subject should be willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diabetic Individual, type I/II diabetics, Gestational Diabetes 2.Subject taking Metformin 3. Subject who has been diagnosed to have acute infections like viral fever, typhoid, cold, diarrhoea within one month prior to enrolment. 4.Subject with complications such as respiratory disorders, cancer or heart attack and stroke 5. History of malignancy in the past 1 year. 6.Having any eating disorder or Lactose intolerance 7.History of hypoglycaemia in last 3 months 8.Taking any herbal/Ayurveda/Traditional preparation that could profoundly affect blood glucose 9.Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of glycemic index value of high protein high fiber nutritional product in comparison to standard glucose solutionTimepoint: Blood sugar will be measured at specific time points over the next three hours i.e. 0, 15, 30, 45, 60, 90, 120 and 150 minutes (±5 minutes window period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose response (Cmax) and time for peak plasma concentration (Tmax) of high protein high fiber nutritional product in comparison to standard glucose solutionTimepoint: Blood sugar will be measured at specific time points over the next three hours i.e. 0, 15, 30, 45, 60, 90, 120 and 150 minutes (±5 minutes window period);Determination of glucose response value of high protein high fiber nutritional product in comparison to standard glucose solution (IAUC)Timepoint: Blood sugar will be measured at specific time points over the next three hours i.e. 0, 15, 30, 45, 60, 90, 120 and 150 minutes (±5 minutes window period);Incidence of Adverse Event (AE) and Serious Adverse Events (SAEs) during the study periodTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactRachana Bhoite
Dr. Reddys Laboratories
Outcome results
None listed