| CTRI Number |
CTRI/2025/08/093737 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess if flaxseed can improve liver health in people with Metabolic dysfunction associated Steatotic liver disease. |
|
Scientific Title of Study
|
Effect of flaxseed supplementation in Metabolic dysfunction associated steatotic liver disease- a randomised control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Babu |
| Designation |
Junior resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
Junior resident (academic)
Department of Medicine
AIIMS,New Delhi
South
DELHI
110049
India |
| Phone |
9072309438 |
| Fax |
|
| Email |
meenakshibabu2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upendra Baitha |
| Designation |
Additional professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Additional professor
Department of Medicine
AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
9266969055 |
| Fax |
|
| Email |
drupendrabaitha@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upendra Baitha |
| Designation |
Additional professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Additional professor
Department of Medicine
AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
9266969055 |
| Fax |
|
| Email |
drupendrabaitha@aiims.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS delhi |
| Address |
Ansari nagar, 110049 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meenakshi Babu |
AIIMS,New delhi |
Department of medicine
Aiims New Delhi, Ansari nagar, Delhi
South
DELHI |
9072309438
meenakshibabu2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flaxseed supplementation |
30 g of flaxseed will be supplemented daily for a period of 12 weeks along with standard of care in intervention group. |
| Comparator Agent |
Standard of care for metabolic dysfunction associated Steatotic liver disease |
Physical exercise, weight loss, dietary measures like calorie restriction,avoiding saturated fatty acids etc |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
MASLD diagnosed on fibroscan or abdominal ultrasound
At least one of cardiometabolic criteria:
1.BMI more than or equal to 25 kg/m2
2.FBS more than or equal to 140 mg/dl or Hba1C more than or equal to 5.7 % or on treatment for type 2 diabetes mellitus
3. BP more than or equal to 130/85 or on antihypertensive treatment.
4.Plasma triglyceride more than or equal to 150 mg/dl or on lip[id lowering agents.
5.Plasma HDL less than. 40 mg.dl in males or less than 50 gm/dl in females. |
|
| ExclusionCriteria |
| Details |
Alcohol consumption more than 20 g/day in females and more than 40 g/day in males.
Intake of drugs causing liver steatosis like amiodarone,methotrexate etc.
Hepatitis C or Hepatitis B
Pregnancy or lactation
Allergy to flaxseeds
Malabsorption syndromes
Hypothyroidism
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in liver steatosis in terms of Fibroscan CAP value |
At the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in anthropometric and metabolic parameters like FBS , lipid profile |
At the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to assess the efficacy of flax seed supplementation in Metabolic dysfunction associated steatotic liver disease in terms of liver steatosis (fibroscan CAP VALUE),metabolic and anthropometric parameters. A total of 60 participants will be divided into two group.The intervention group will receive 30 g of flaxseed daily for a period of 12 weeks along with standard of care and control group will receive standard of care treatment.The result of the study will help in assessing whether flaxseed supplementation can be used an adjunct to standard of care treatment for MASLD in future. |