Effect of nutrition supplement on Glycemic Response in Adults with Type 2 Diabetes

Not yet recruiting

Conditions: Diabetes mellitus due to underlying condition without complications,

Brief Summary: Study is to evaluate the effect of diabetes specific nutrition supplement (HUL Diabetes Nutrition supplement-Horlicks diabetes plus) administered for 12 weeks (along with nutrition counselling) in Glucose Management with glycemic markers (fasting and postprandial blood glucose, HbA1c, 24hrs IAUC, MAGE, TIR) as compared to control group with only nutrition counselling.

Recruitment & Eligibility

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.

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.

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.	2 time points baseline and end of 12 weeks study period. \| 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 pressure	2 time points baseline and end of 12 weeks study period.

Locations (1): Madras Diabetes Research Foundation
🇮🇳
Chennai, TAMIL NADU, India
Madras Diabetes Research Foundation
🇮🇳Chennai, TAMIL NADU, India
Sudha Vasudevan
Principal investigator
s2r_7@mdrf.in