| 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
|
|
|
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
|
|
|
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. |