CTRI

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CTRI Number

CTRI/2024/02/062783 [Registered on: 19/02/2024] Trial Registered Prospectively

Last Modified On:

17/02/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Behavioral

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Study of intermittent fasting to check whether it can cause weight loss improve liver function and quality of life and normalise blood pressure in fatty liver patients when compared to those not following intermittent fasting

Scientific Title of Study

To compare the weight loss Liver function tests blood pressure and quality of life in patients of metabolic syndrome and or NAFLD with and without Time restricted eating an open label 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 RIMPLE JEET KAUR
Designation	Assistant Professor
Affiliation	All India institute of medical sciences jodhpur
Address	Dr Rimple Jeet Kaur Assistant Professor Department of pharmacology Second floor AIIMS college AIIMS Jodhpur Basni phase 2 Rajasthan Dr Rimple Jeet Kaur Assistant Professor Department of pharmacology Second floor AIIMS college AIIMS Jodhpur Jodhpur RAJASTHAN 342005 India
Phone	9784525975
Fax
Email	sidhurimple@yahoo.com

Details of Contact Person
Scientific Query

Name	DR RIMPLE JEET KAUR
Designation	Assistant Professor
Affiliation	All India institute of medical sciences jodhpur
Address	Dr Rimple Jeet Kaur Assistant Professor Department of pharmacology Second floor AIIMS college AIIMS Jodhpur Basni phase 2 Rajasthan 342005 Dr Rimple Jeet Kaur Assistant Professor Department of pharmacology Second floor AIIMS college AIIMS Jodhpur Jodhpur RAJASTHAN 342005 India
Phone	9784525975
Fax
Email	sidhurimple@yahoo.com

Details of Contact Person
Public Query

Name	Dr Simi Bridjit Gomaz
Designation	Junior resident
Affiliation	All India institute of medical sciences jodhpur
Address	Room 250 Department of pharmacology Second floor college building AIIMS Jodhpur Basni phase 2 Rajasthan Room 250 Department of pharmacology Second floor college building AIIMS Jodhpur Basni phase 2 Rajasthan Jodhpur RAJASTHAN 342005 India
Phone	9526913252
Fax
Email	simibridjitgomaz77@gmail.com

Source of Monetary or Material Support

All India Institute of medical sciences jodhpur

Primary Sponsor

Name	Non funded study All India Institute of medical sciences jodhpur
Address	All India Institute of medical sciences Jodhpur Basni phase 2 Rajasthan 342005
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
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 Rimple Jeet Kaur	All India Institute of medical sciences Jodhpur	Department of general medicine Block A First floor OPD building All India Institute of medical sciences hospital jodhpur Jodhpur RAJASTHAN	9784525975 sidhurimple@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee AIIMS Jodhpur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E660\|\|Obesity due to excess calories,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	standard of care	standard of care for NAFLD/ metabolic syndrome - based on the standard treatment guidelines the clinician provides standard of care for NAFLD / metabolic syndrome as per the diagnosis
Intervention	Time restricted eating	The test group will be advised time-restricted eating for 14 hours by fixing a feeding window of 9 am to 7 pm to ensure 14 hours of fasting and gradually reducing the feeding window to reach 16 hours if tolerated.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Diagnosed case of metabolic syndrome and or Nonalcoholic fatty liver disease Age between 18 and 75 years Body mass index of greater than or equal to 25 kilogram per metre square

ExclusionCriteria

Details

Pregnancy or lactation
Inherited or acquired immunodeficiency
On immunosuppressive drugs
On insulin or insulin secretagogues
Malignancies
Mental illness
Chronic kidney disease with estimated glomerular filtration rate eGFR less than or equal to30
Aspartate aminotransferase or Alanine transaminase more than three times the upper limit of normal

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Liver function tests at baseline and at 12 weeks	Liver function tests at baseline and at 12 weeks

Secondary Outcome

Outcome	TimePoints
quality of life through a questionnaire of patients included in the study QOL will be assessed using the WHO BREF questionnaire.	At baseline and after 3 months
weight loss in terms of Body Mass Index	At baseline and after 3 months
mean blood pressure	At baseline and after 3 months
Fasting lipid profile	At baseline and after 3 months

Target Sample Size

Total Sample Size="193"
Sample Size from India="193"
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/ Phase 3

Date of First Enrollment (India)

26/02/2024

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="2"
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 study will be an open label interventional study involving the diagnosed cases of metabolic syndrome or NAFLD meeting the defined inclusion and exclusion criteria and providing informed consent within one year of ethics committee approval

All the patients in the study will be divided into two groups Permuted block randomization will be done to avoid confounding and bias Baseline characteristics will be recorded before the intervention and follow up will be done at 0 and 3 months Both groups will be given routine standard of care a balanced diet vitamin E supplements and probiotics and exercise therapy per the clinician advice The test group will be advised time restricted eating for 14 to 16 hours by fixing a feeding window of 9 am to 7 pm to ensure 14 to 16 hours of fasting and gradually reducing the feeding window to reach 16 hours if tolerated BMI mean office BP liver function tests and lipid profile will be assessed at baseline after three months The questionnaire will evaluate the quality of life

This will be a study of 3 month duration and patient follow up will be done from 0 to 3 months Assessment of the efficacy parameters will be done at baseline and the end of the study The parameters measured will be systolic blood pressure and diastolic BP which will be measured when the patient arrives in OPD using the automated BP apparatus Three readings one minute apart will be taken and the mean of the last two readings will be calculated and recorded Liver function tests and lipid profiles will be obtained by taking blood samples QOL will be assessed using the WHO BREF questionnaire and scores will be recorded before and after three months Body weight in kg height in meters and waist and hip circumference will also be recorded.BMI will be calculated