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High Protein Diet and Hepatic Steatosis in patients with Metabolic dysfunction associated fatty liver disease

Effect of high protein diet on hepatic steatosis, inflammation and mitochondrial bioenergetics in patients with MAFLD : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079094
Enrollment
170
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: 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. Control Intervent

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed treatment naive consenting adults with MAFLD (controlled attenuation parameter; CAP more than 250. 2. Age 18-65 years

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Improvement in Hepatic SteatosisTimepoint: 3 months

Secondary

MeasureTime frame
1.Changes in systemic bioenergetics 2.Changes in cellular bioenergetics 3.Changes in metabolic features 4.Change in muscle massTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Jaya Benjamin

Institute of Liver and Biliary Sciences

jayabenjaminilbs@gmail.com9540951081

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026