| CTRI Number |
CTRI/2024/11/076270 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of restricting the time of meals in fatty liver disease |
|
Scientific Title of Study
|
Efficacy of time restricted eating in patients of non alcoholic fatty liver disease: A
chronophysiological interventional study |
| 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 Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI lucknow |
| Address |
Dept of hepatology, CHBDT SGPGIMS
Sanjay gandhi post graduate institute of medical sciences, raebarelli road Lucknow
226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI lucknow |
| Address |
Dept of hepatology, CHBDT SGPGIMS
Sanjay gandhi post graduate institute of medical sciences, raebarelli road Lucknow
226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI lucknow |
| Address |
Dept of hepatology, CHBDT SGPGIMS
Sanjay gandhi post graduate institute of medical sciences, raebarelli road Lucknow
226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay gandhi postgraduate institute of medical sciences, lucknow,UP, INDIA
Pincode:226014 |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [N/A] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
N/A |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay kumar Mishra |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
Hepatology OPD ,4th floor NEW OPD BLOCK
Lucknow
UTTAR PRADESH |
9532870267
ajaymishrapandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGI Institute ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hypocaloric diet |
500 Kcal less than basal energy expenditure for 12 weeks |
| Intervention |
Time restricted eating |
Timing of meals will be restricted from 9 am to 6pm for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with NAFLD(defined by USG suggestive of steatosis with raised liver enzymes) between 18 yrs to 60 yrs |
|
| ExclusionCriteria |
| Details |
Patients with other liver diseases, diabetics, pregnancy and chronic systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in insulin resistance as measured by Mean reduction in HOMA IR at 12 weeks. |
Improvement in insulin resistance as measured by Mean reduction in HOMA IR at 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in steatosis as measured by proportion of patients acheiving atleast one grade decrease in steatosis as per USG
Mean change in liver stiffness(LSM) at day 90 as measured by fibroscan |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/11/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Patients will be randomised in 2 groups, Group A will receive hypo-caloric diet calculated as 500 kcal deficit on basal energy expenditure and Group B will receive Hypocaloric diet with restriction of time of meals from 9 am to 6 pm. All patient will be advised exercise as per guidelines and will be followed weekly for 4 weeks followed by once a month. Patients will under go detailed history including life style details and eating behaviours along with anthropometric measurement. All patients will be counselled by registered dietician as per above followup. Primary objective is to study mean improvement in HOMA IR at 12 weeks. secondary objective is to study changes in liver stiffness, steatosis measured by CAP ,changes in lipids, blood pressure, blood sugar ,weight, BMI and waist hip ratio. Based on previous studies we planned to enrol 76 patients with power of 80% and alpha error of 5%. |