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CTRI Number  CTRI/2025/05/086849 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [nutrition and exercise]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of calorie restricted diet combined with resistance training versus unrestricted physical activity on liver fat content in patients with non alcoholic fatty liver: A RCT 
Scientific Title of Study   Effectiveness of calorie restricted diet combined with structured resistance training versus ad libitium physical activity on hepatic steatosis in patients with non-alcoholic fatty liver: A RCT. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika Maan 
Designation  Ph.D Scholar 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. A-4,1st Floor, Aadhyan Hostel, ILBS, Vasant Kunj
Room No A-4,1st Floor, Aadhyan Hostel, ILBS, Vasant kunj.
New Delhi
DELHI
110070
India 
Phone  8920288088  
Fax    
Email  monikamaan.2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mini George 
Designation  Principal 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Principal, College of Nursing, ILBS,Vasant Kunj
Principal, College of Nursing, ILBS,Vasant Kunj
New Delhi
DELHI
110070
India 
Phone  8920288088  
Fax    
Email  principalcon@ilbs.in  
 
Details of Contact Person
Public Query
 
Name  Monika Maan 
Designation  Ph.D Scholar 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Room No. A-4,1st Floor, Aadhyan Hostel,ILBS, Vasant Kunj
Room No. A-4,1st Floor, Aadhyan Hostel,ILBS, Vasant Kunj
New Delhi
DELHI
110070
India 
Phone  8920288088  
Fax    
Email  monikamaan.2011@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTE OF LIVER AND BILIARY SCIENCES, D-1, VASANT KUNJ, NEW DELHI, INDIA PIN CODE-110070 
 
Primary Sponsor  
Name  Institute of Liver and Biliary Sciences 
Address  INSTITUTE OF LIVER AND BILIARY SCIENCES, D-1, VASANT KUNJ, NEW DELHI, INDIA. PIN CODE-110070 PIN CODE-110070 
Type of Sponsor  Research institution and hospital 
 
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 Anoop Saraya  Institute of Liver and Biliary Sciences, New Delhi  Outpatient Clinic, Room No- 2041, Section-B, D-1, Vasant Kunj, New Delhi
South
DELHI 
9717830982

ansaraya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
College of Nursing, Ethics Committe, ILBS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Ad libitum physical activity   ad libitum physical activity refers to spontaneous, self-directed, and unstructured movements carried out without set guidelines or limitations. It includes activities performed at an individuals own pace, with varying intensity and duration based on personal preference and motivation.The total duration of intervention will be 6 months and patient will be followed up at 1 month, 3 month and 6 months physically and every two week telephonically. 
Intervention  STRUCTURED RESISTANCE TRAINING EXERCISE  structured resistance training is a carefully planned and organized exercise regimen under the guidance of a physiotherapist aimed at improving muscular strength, endurance, and overall fitness. The program will include specific exercises, sets, repetitions at 70-80% 1 RM (one rep max), intensity levels, and rest periods incrementally (with 50% of their repetitions, progressing to 70% and 100 % after one-week completion through provided video), all tailored to meet individual fitness goals.It incorporates warm-up (5-10 minutes), main workout (specific exercises) for 30-35 minutes, and cool-down (5-10 minutes). The total duration of intervention will be 6 months and patient will be followed up at 1 month, 3 month and 6 months physically and every two week telephonically. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient aged between 18-65 years
2. Newly diagnosed cases of non-alcoholic fatty liver via transient elastography
3. Ability to give informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Any known secondary liver disease, including hepatitis B surface antigen or anti-hepatitis C virus antibodies.
2. Excessive alcohol consumption
3. Administration of medical treatment that may elevate alanine aminotransferase (ALT) or lead to hepatic steatosis (Drugs like amiodarone, risperidone, olanzapine, and valproic acid, etc).
4. Known diabetes and on multiple oral hypoglycaemic agents, or insulin.
5. Pregnant females, irrespective of gestational age.
6. Major chronic diseases including: renal, cardiovascular, lung, uncontrolled hypertension, inflammatory bowel disease, any malignancy and autoimmune disorders.
7. Orthopaedic contraindications for structured resistance training.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
effectiveness of calorie-restricted diet combined with structured resistance training versus ad libitium physical activity on hepatic steatosis as assessed by Controlled Attenuation Parameter values in patients with non-alcoholic fatty liver   BASELINE, 1MONTH, 3MONTH AND 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
changes in Anthropometric, Body composition, Cardiometabolic, Biochemical parameters and hand grip strength among both the groups   BASELINE, 1MONTH, 3MONTH AND 6 MONTHS 
 
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)   01/10/2025 
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="6"
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  

Non-Alcoholic Fatty Liver Disease is a chronic condition marked by excessive fat accumulation in the liver, not linked to alcohol consumption. Globally, it affects 25–29% of the population, with prevalence in Asia, including India, ranging from 9% to 53%, influenced by demographics and socioeconomic factors. NAFLD can progress to severe liver conditions like NASH, fibrosis, cirrhosis, or liver cancer. It also increases the risk of cardiovascular diseases, metabolic syndrome, diabetes, and kidney disorders. The healthcare costs associated with NAFLD have risen significantly and each one-unit increase in FIB-4 scores correlates with a 3.4% rise in overall healthcare expenses. So, early intervention in terms od diet and lifestyle modification is crucial to curb these escalating costs.

Lifestyle modifications, including dietary changes and physical activity, are pivotal in NAFLD management. Calorie-restricted diets, such as low-carbohydrate, Mediterranean, and ketogenic approaches, have shown promise in reducing hepatic fat and improving metabolic health.

                   Different type of exercise like aerobic and resistance training offers unique and complementary benefits to individuals but, resistance training has additional benefits in terms of building and maintaining lean muscle mass, reducing risk of injury, feasibility in cardiopulmonary compromised and obese patients. So, it is important to make use of this modality in NAFLD management.

Although resistance exercise is promising for NAFLD management but, significant research gaps exist regarding its optimal application, standardized protocols, duration and clinical outcomes. So, we hypothesized that a calorie-restricted diet combined with structured resistance training (150 minutes/week) will be feasible and effective.

 
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