Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD

NCT06749704 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Not applicable

Started

2024-12-27

Last updated

2024-12-27

Condition(s) studied

Metabolic Dysfunction Associated Fatty Liver Disease

Investigational drug(s) / intervention(s)

High protein dietNormal Protein diet

High protein diet: High protein diet

Normal Protein diet: Normal protein diet

Study summary

MAFLD 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP \>250, BMI\>23 and/or DM) Age 18-65 years Exclusion Criteria: * • Lean (BMI \<23) patients * Age \<18 and \>65 years * Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months * Patients with viral hepatitis * Patients with significant alcohol consumption (regular consumption of \> 10g per day for females and \> 20g/d in males), * Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded * Pregnant \& lactating women

Primary outcome measure(s)

Assessment of Hepatic steatosis. — 3 months
Changes in hepatic steatosis at baseline and follow up would be done using fibro scan (CAP) and Computed Tomography (Liver Attenuation Index).

Trial sites (1)

Facility	City	Region	Status
Institute of Liver and Biliary Sciences	Delhi	New Delhi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06749704 on ClinicalTrials.gov ↗ ← All trials in India