Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Diabetes Specific Protein Supplement (DSPS): 25g of Diabetes specific protein supplement (DSPS) with 200 ml milk with reduced quantity (30g) of dehydrated upma or poha.
Control Interven
Sponsors
Nutricia International Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: People with T2D (with duration of diabetes morethan 6 months) and treated with oral antidiabetic drugs stable for at least 2 months or controlled with diet alone. HbA1c 7-9% (7 & 9% included) In case of People with T2D with hypertension, it needs to be treated and well controlled. In case of People with T2D with dyslipidemia, it needs to be treated and well controlled. BMI between 18.5-29.9 (18.5 & 29.9 included) People on home remedies or taking diabetes specific nutrition formula would be asked to practice abstinence from these foods/formulations at least for a week before study and during the study. Willing to comply with the study protocol Written informed consent
Exclusion criteria
Exclusion criteria: People with Type 1 DM People with Type 2 DM on insulin or acarbose or short acting sulfonylurea (e.g.meglitinide) medication or GLP 1 analogues Pregnant women Lactating mothers People with uncontrolled diabetes, HbA1c more than 9.0.% People with significant heart disease (uncontrolled dyslipidemia - fasting S. cholesterol more than 260mg /dL and S. triglycerides more than 300mg/dL) on screening visit People with presence of any severe diabetic complication and/or major systemic disease. People with renal disease, S. Creatinine more than 1.5mg/dL, requiring dialysis People with liver disease, AST and ALT more than 2.5times the upper normal limits People with recent history of stroke or unstable angina or coronary artery diseases in the last six months before inclusion. Presence of ketone bodies in urine analysis. People with IBS, IBD, chronic acidity, and bloating Hemoglobin level below 10 gm%. History of substance abuse or alcoholism in the past one year. People who have been infected with HIV/Hepatitis B or Hepatitis C or COVID in the last 3 months as per information given by people. People who had a major infection in the past 3 weeks and have been treated with antibiotics. People who are on corticosteroids or oral contraceptives. People in any clinical trials within 30 days of admission to the study. Known allergies or intolerance to milk, soy, lactose or any component of the test product People following veganism. People with IBS, IBD, chronic acidity, and bloating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post prandial glucose response (iAUC)Timepoint: at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Post prandial insulin area under the curve, Postprandial peak glucose (mg/dl), Postprandial peak insulin (µU/mL), Maximum postprandial glucose increase from baseline (delta peak), Maximum postprandial insulin increase from baseline (delta peak)Timepoint: at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min | — |
Countries
India
Contacts
Public ContactMs Sheryl S Salis
Nurture Health Solutions
Outcome results
None listed