| CTRI Number |
CTRI/2023/01/049210 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
24/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional beverage] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nutrition supplement on Glycemic Response in Adults with Type 2 Diabetes |
|
Scientific Title of Study
|
Effect of Diabetes-specific Nutrition Supplement on Glycemic Response in Adults with Type 2 Diabetes: a 12-week randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
President & Chief of Diabetes Research |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Madras Diabetes Research Foundation (MDRF)
6B, Conran Smith Road,
Gopalapuram,
Chennai - 600086, Tamil Nadu
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Khanna |
| Designation |
Clinical Research & Claims Capability Leader, HFD |
| Affiliation |
Hindustan Unilever Limited |
| Address |
Hindustan Unilever Limited
Nutrition Research and Development Centre
Plot Number 67, Sector 32, Gurgaon -122001
Haryana, India
Gurgaon
HARYANA
12001
India |
| Phone |
124-4097100 |
| Fax |
|
| Email |
deepti.khanna2@unilever.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Khanna |
| Designation |
Clinical Research & Claims Capability Leader, HFD |
| Affiliation |
Hindustan Unilever Limited |
| Address |
Hindustan Unilever Limited
Nutrition Research and Development Centre
Plot Number 67, Sector 32, Gurgaon -122001
Haryana, India
Gurgaon
HARYANA
12001
India |
| Phone |
124-4097100 |
| Fax |
|
| Email |
deepti.khanna2@unilever.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited
Unilever House,
B D Sawant Marg Chakala,
Andheri East Mumbai 400099 |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No.6B Conransmith Road,
Gopalapuram,
Chennai-600086 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Hindustan Unilever Limited |
Unilever House, B D Sawant Marg Chakala, Andheri East Mumbai 400099 |
| SIRO Clin Pharm Pvt Ltd |
Kalpataru Prime, 1st floor, Unit Nos. 3 & 4, Road No. 16, Wagle Industrial Estate, Thane (W), Maharashtra 400 604, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sudha Vasudevan |
Madras Diabetes Research Foundation |
Department of foods nutrition dietetics research
6B Conron Smith Road
Gopalapuram
Chennai
TAMIL NADU |
439688888
s2r_7@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Routine diet and physical activity for 12 week study period |
| Intervention |
Intervention |
Horlicks diabetes plus with water will be given daily as a pre breakfast and bed time beverage for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
having fasting Blood Glucose (FBG) greater than equal to 126– 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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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.
Anthropometric measurements will also be measured monthly once
|
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |