Not Yet RecruitingNot Applicable

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

India140 participantsStarted 2024-12-27

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assessment of Hepatic steatosis.

Timeframe: 3 months

Trial details

NCT IDNCT06749704

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Kanika Jain, MSc

08076030183 kanikjain@gmail.com

View on ClinicalTrials.gov More Metabolic Dysfunction Associated Fatty Liver Disease trials