Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Muesli: High fibre, high protein food items along with micronutrients specially developed for diabetic subjects. Administered once per subject during the trial period of 5 months.
Inter
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and/or Female subject with the age group 30 to 65 years. 2. The subject should be diagnosed to have Type II Diabetes Mellitus (at least 3 years in duration) 3. 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) 4. The subject should have a Haemoglobin A1c (HbA1c) in the range of 7 % to 10%, done within 3 months of enrolment. 5. The subject should be on treatment with Oral Anti-diabetic medications with stable doses for at least 3 months 6. The subject should be willing to refrain from smoking, alcohol and caffeine containing drinks during the study period. 7. The subject should be willing to comply with study protocol requirements. 8. The subject should be willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject taking Insulin 2. Subject who has been diagnosed to have acute infections like viral fever, typhoid, cold, diarrhoea within one month prior to enrolment. 3. Subject with complications such as respiratory disorders, cancer or heart attack and stroke 4. History of malignancy in the past 1 year. 5. Having any eating disorder or Lactose intolerance 6. History of hypoglycaemia in last 3 months 7. Taking any herbal/Ayurveda/Traditional preparation that could profoundly affect blood glucose 8. Pregnant and lactating women 9. Plans to relocate in the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of glycemic index value of Muesli and BiscuitsTimepoint: Blood sugar will be measured at specific time points over the next three hours i.e. 0, 15, 30, 45, 60, 90, 120 and 180 minutes (±5 minutes window period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose response (Cmax) and time for peak plasma concentration (Tmax) of Muesli and Biscuits.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 180 minutes (±5 minutes window period);Determination of glucose response value of Muesli and Biscuits in comparison to that of white bread (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 180 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 ContactDr Amey Mane
Dr. Reddys Laboratories Ltd
Outcome results
None listed