| CTRI Number |
CTRI/2025/01/079094 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [High Protein Diet ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
High Protein Diet and Hepatic Steatosis in patients with Metabolic dysfunction associated fatty liver disease |
|
Scientific Title of Study
|
Effect of high protein diet on hepatic steatosis, inflammation and mitochondrial bioenergetics in patients with MAFLD : A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanika Jain |
| Designation |
Project Research Scientist-I, Dept. of Clinical Nutrition |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Nutrition
Third floor,Cubicle No-5,Phase -1
D-1,Vasant Kunj, Institute of liver and Biliary Sciences
South West
DELHI
110070
India |
| Phone |
9540951081 |
| Fax |
|
| Email |
kanikjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Benjamin |
| Designation |
Associate Professor, Dept. of Clinical Nutrition |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Nutrition
Third floor,Faculty Room,Phase-2
D-1,Vasant Kunj, Institute of liver and Biliary Sciences
South West
DELHI
110070
India |
| Phone |
9540951081 |
| Fax |
|
| Email |
jayabenjaminilbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Benjamin |
| Designation |
Associate Professor, Dept. of Clinical Nutrition |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Nutrition
Third floor, Faculty room, Phase-2
D-1,Vasant Kunj, Institute of liver and Biliary Sciences
South West
DELHI
110070
India |
| Phone |
9540951081 |
| Fax |
|
| Email |
jayabenjaminilbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research AIIMS Campus Temple, ANSARI NAGAR,Near GATE NO-2,New Delhi,110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
AIIMS Campus Temple, ANSARI NAGAR,Near GATE NO-2,New Delhi,110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Kanika Jain |
Institute of Liver and Biliary Sciences |
Department of Clinical Nutrition
Phase-2 ,Faculty room
D-1,Vasant Kunj, Institute of Liver and Biliary Sciences
New Delhi
DELHI |
8076030183
kanikjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee(IEC)/Institutional Review Board(IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High protein Group |
High protein diet of 25% would be given to patients with MAFLD for a period of three months. Main sources of protein would be pulses,diary,legumes. |
| Comparator Agent |
Normal Protein Group |
Normal Protein intake of 15% would be given to patients with MAFLD for a period of three months.This is a normal calorie-restricted diet. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed treatment naive consenting adults with MAFLD (controlled attenuation parameter; CAP more than 250.
2. Age 18-65 years
|
|
| ExclusionCriteria |
| Details |
1.Lean (BMI less than 23)
2.Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
3.Patients with viral hepatitis
4.Patients with significant alcohol consumption (regular consumption more than 10g per day for females and more than 20g/d in males),
5.Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
6.Pregnant & lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hepatic Steatosis |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in systemic bioenergetics
2.Changes in cellular bioenergetics
3.Changes in metabolic features
4.Change in muscle mass |
3 months |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
01/02/2025 |
| 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="3"
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
|
NAFLD is a growing problem in India. Its
pathophysiology is complex, but focused on abnormal substrate handling due to
mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is
the cornerstone of management. The ideal macronutrient distribution within a
hypocaloric diet is not known yet. Evidence from experimental and a few human
studies in obese, highlight the role of dietary proteins, independent of
calorie restriction, in reducing hepatic steatosis by improving the cellular
and systemic bioenergetics.
Novelty: First study to assess the effect of high protein
diet (HPD) in comparison to a standard protein diet (SPD) within a calorie
restricted diet, on both the cellular and systemic bioenergetics in patients
with NAFLD.
Objectives: Aims to see the effect of HPD on hepatic steatosis,
cellular and systemic bioenergetics, along with metabolic parameters in
patients with NAFLD.
Method: In this RCT, patients with MAFLD (n=140) with or
without MS, would be randomized into HPD or SPD groups (i.e. 70 in each group),
and parameters like hepatic steatosis (CAP by Transient elastography
(FibroScan), cellular bioenergetics by oxygen consumption rate (OCR) and
extracellular acidification rate (ECAR) as measured using Seahorse Analyzer,
and Indirect Calorimetry will be used to assess the fasting and postglucose
challenge (Oral glucose tolerance test) REE and RQ. DEXA scan would be used to
assess body composition apart from routine blood tests to assess features of
Metabolic syndrome. The serum levels of GLP1, CKK, Ghrelin, FGF21, Adipokines
like leptin and adiponectin, NADH/NAD ratio, insulin and glucagon would be
measured.
Outcome: A HPD is expected to improve hepatic steatosis,
blunted fuel switching (RQ) and cellular bioenergetics (OCR) along with
metabolic parameters in patients with NAFLD. |