Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
Conditions
Interventions
Intervention1: Intervention: Horlicks diabetes plus with water will be given daily as a pre breakfast and bed time beverage for 12 weeks
Control Intervention1: Control group: Routine diet and physical
Sponsors
Madras Diabetes Research Foundation
Hindustan Unilever Limited
SIRO Clin Pharm Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: having fasting Blood Glucose (FBG) greater than equal to 126â?? less than equal to 180 mg/dL. Diabetic for at least one year. On Oral hypoglycaemic Agents (OHA) with stable doses for at least 3 months. Willing to follow study protocol. Willing to give informed consent
Exclusion criteria
Exclusion criteria: BMI less than 18.0 and greater than 30.0 kg per meter squared. On insulin injections. Having alterations of dosages of OHA in the last 3 months. Any acute infections like viral fever, typhoid, cold, diarrhea, constipation in the last 1 month. Having diabetes induced/related complications [nephropathy, retinopathy]- thyroid dysfunction, respiratory disorders, cancer or heart attack and stroke. Having any eating disorder or lactose intolerance. Taking any herbal/Ayurvedic/traditional preparation/nutrition supplements that could profoundly affect blood glucose. Pregnant and lactating women. Plans to relocate in the next 1 years. Planning longer duration of travel out of town. Enrolled in any other clinical trial. Participated in a clinical study in the last 3 months. Employee of the site conducting the study. Participants with habitual abuse (Alcohol, smoking, tobacco) substance consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of diabetes specific nutrition supplement (HUL Diabetes Nutrition supplement-Horlicks diabetes plus) administered for 12 weeks on glycemic markers (fasting and postprandial blood glucose, HbA1c, 24hrs IAUC, MAGE, TIR) as compared to control group.Timepoint: 2 time points baseline and end of 12 weeks study period. In addition HbA1c will be measured on 45th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of the diabetes specific nutrition supplement administered for 12 weeks on the secondary outcomes such as body weight, satiety, waist circumference, lipid profile and blood pressureTimepoint: 2 time points baseline and end of 12 weeks study period. Anthropometric measurements will also be measured monthly once | — |
Countries
India
Contacts
Public ContactDr Deepti Khanna
Hindustan Unilever Limited
Outcome results
None listed