| CTRI Number |
CTRI/2025/07/091285 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [DIET] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Whether any Changes in blood sugar level in people with type 2 Diabetes taking a standard meal in dinner in comparison to Millet based dinner |
|
Scientific Title of Study
|
Comparison of Little Millet based Dinner
Versus a standard diet on Glycaemic Control Among Type 2 Diabetic Patients From Eastern India: A
randomized open label pilot trial |
| Trial Acronym |
MILLET-DIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Naskar |
| Designation |
Assistant Professor |
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16
Department of Endocrine, Nutrition and metabolic diseases
108 CR Avenue
School of Tropical Medicine
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Naskar |
| Designation |
Assistant Professor |
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16
Department of Endocrine, Nutrition and metabolic diseases
108 CR Avenue
School of Tropical Medicine
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Naskar |
| Designation |
Assistant Professor |
| Affiliation |
School of Tropical Medicine |
| Address |
Room No 16
Department of Endocrine, Nutrition and metabolic diseases
108 CR Avenue
School of Tropical Medicine
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Tropical Medicine
108 CR Avenue, Kolkata-700073,
India |
|
|
Primary Sponsor
|
| Name |
Dr Arindam Naskar |
| Address |
Room No 16,
Department of Endocrine Nutrition and metabolic diseases,
108 CR Avenue, Kolkata-700073
School Of Tropical Medicine |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arindam Naskar |
School of Tropical Medicine |
Room No. 16, Dept. of Endocrinology, Nutrition and Metabolic diseases
108, CR Avenue, Kolkata
Kolkata
WEST BENGAL |
7044007741
indrani.bbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Little Millet |
Little Millet based dinner will include 40 grams of little millet in dinner in place of rice |
| Comparator Agent |
Standard meal |
Standard meal will involve 40 gram rice based dinner |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
With written informed consent
HbA1C: 7-9 Percentage
Age: 18 to 65 years
Patients already on oral hypoglycaemic agents |
|
| ExclusionCriteria |
| Details |
Presence of: Type 1 diabetes
Patients with BMI more than 40
Pregnant and lactation
Patients with history of renal disease (eGFR less than 60), chronic liver disease, malignancies,
heart failure (NYHA III and IV), uncontrolled thyroid diseases, Cushing’s disease,
autoimmune diseases, HIV and other disease that can affect body weight, any
haematological disorders.
History of current eating disorders or current smoking
Patient on high dose of steroids
Patient on hormonal therapy
Patients on insulin therapy
Having any intolerance to Little Millet
Non consenting patient |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the change in HbA1C in type 2 diabetic patients receiving Little Millet
based dinner as compared to Standard diet |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the changes in the following health parameters:-
a) Body Mass Index (BMI)
b) Waist circumference and Waist Hip Ratio(WHR)
c) Fasting Blood Glucose(FBG),
d) Post Prandial Blood Glucose(PPBG)
e) Lipid Profile
f) Alanine Transaminase (ALT) and Aspartate Aminotransferase(AST)
g) Urea, Creatinine, Urine Albumin-Creatinine Ratio (ACR) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Little Millet, known for its low glycemic index and high fiber content, may offer advantages over conventional rice based dinners which is common in Bengal. There is paucity of studies from Eastern part of India regarding effectiveness of Little Millet based diet for glycemic control in diabetics. This study aims to evaluate the effects of little millet based dinner of diabetic patients in West Bengal. By focusing on the evening meal, the study addresses a critical period as blood glucose level typically rise at early morning, potentially exacerbating hyperglycemia. The findings could provide evidence for dietary interventions tailored to local preferences and agricultural practices, promoting sustainable and culturally acceptable dietary changes |