Effect of nutrition supplement on Glycemic Response in Adults with Type 2 Diabetes
- Conditions
- Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
- Registration Number
- CTRI/2023/01/049210
- Lead Sponsor
- Madras Diabetes Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>In addition HbA1c will be measured on 45th day.
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>Anthropometric measurements will also be measured monthly once <br/ ><br>