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Clinical Trials in India / NCT06749704
Starting soon Not applicable

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
No
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)

FacilityCityRegionStatus
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