| CTRI Number |
CTRI/2026/04/107362 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of oats fiber on glycemic control in Indian adults with type 2 diabetes. |
|
Scientific Title of Study
|
Effect of oats containing ß-glucan supplementation on glycemic control in Indian adults with type 2 diabetes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lisa Sarkar |
| Designation |
PhD Scholar |
| Affiliation |
Sister Nivedita University |
| Address |
DG 1/2 New Town
Action Area 1, Kolkata - 700156
Department of Applied Nutrition and Dietetics.
Room no 703
Kolkata
WEST BENGAL
700156
India |
| Phone |
1800 258 8155 |
| Fax |
NIL |
| Email |
deputyregistrar@snuniv.ac.in. |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Naskar |
| Designation |
Incharge Dept. of Endocrine and Nutrition |
| Affiliation |
School of Tropical Medicine |
| Address |
108, CR Avenue, Kolkata
Department of Endocrine and Nutrition.
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
NIL |
| Email |
dr.arindam.naskar.83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lisa Sarkar |
| Designation |
PhD Scholar |
| Affiliation |
Sister Nivedita University |
| Address |
DG 1/2, New Town, Action Area1,
Kolkata - 700156
Department of Applied Nutrition and Dietetics.
room no 703
Kolkata
WEST BENGAL
700156
India |
| Phone |
8420446082 |
| Fax |
NIL |
| Email |
lisasarkar2018@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lisa sarkar self |
| Address |
DG 1/2, New Town, Action Area1,
Kolkata - 700156 |
| Type of Sponsor |
Other [Sister Nivedita University private university] |
|
|
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 Kolkata |
108, Chittaranjan Avenue, Kolkata, West Bengal 700073
department of Endocrinology and Nutrition.
Kolkata
WEST BENGAL |
7044007741
dr.arindam.naskar.83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee (CREC- STM) |
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 |
oats containing beta glucan |
Daily 50 grms orally administered oats approximately provides 1.75 to 2.5 grms beta glucan for 3 months |
| Comparator Agent |
Roti make of atta |
Daily dose of 50 grms atta approximately 2pc orally administered during breakfast for 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 60 years.
Diagnosed with type 2 diabetes for more than 6 months.
On stable antidiabetic drug regimen and no change for more than 6 months
Baseline HbA1c 7 to 10 per cent
BMI greater than 23 kg per meter square. According to the Endocrine Society of India, a BMI greater than 23 is considered overweight, and a BMI greater than 25 is considered obesity.
Patient giving informed consent
|
|
| ExclusionCriteria |
| Details |
Use of any extra supplement like psyllium or viscous fiber within 4 weeks.
Significant renal eGFR less than 45, chronic liver disease, recent cardiovascular events, pregnancy and lactation.
Any known history of GI malabsorption, inflammatory bowel disease .
Known intolerance of oats or barley
Patient refuses to give consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Epidemiological data like Age, Sex, Address, Duration of diabetes, Current medications, Comorbidities hypertension, dyslipidemia
2. Clinical data like
BMI, Waist circumference, waist: hip ratio, HbA1C, Lipid profile, ECG, Complete hemogram, AST, ALT or LFT Urine spot ACR.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Change in plasma glucose, insulin, lipid profile (TC, LDL, HDL, TG).
|
From baseline to 12 weeks |
| • Anthropometrics: weight, BMI, waist circumference. Hip circumferences, waist – hip ratio. |
120 weeks |
| • Adverse events and tolerability |
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
09/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/04/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled parallel group trial on the effect of oats containing beta-glucan in 140 Indian diabetic patients. The primary outcome is to measure the changes in HbA1c from baseline to 12 weeks of the intervention. |