Indian-style Mediterranean diet versus low-fat diet to reduce liver fat in overweight children with MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, open-label trial that will enroll children and adolescents aged 8–18 years with BMI above the 85th percentile and elevated liver fat (CAP >236 dB/m). Participants will be assigned to either an Indianized Mediterranean diet or a low-fat diet with recommended physical activity and followed for 180 days. The primary outcome is the proportion achieving normal CAP (<236 dB/m) at day 180; secondary outcomes include changes in CAP, ultrasound fatty liver grade, metabolic measures (weight, BMI, HOMA-IR, lipids), adiponectin and inflammatory cytokines, and adherence by a modified KIDMED score. A planned subgroup analysis will examine responses in children with PNPLA3 variants and routine anthropometry, FibroScan, and laboratory tests will be used to measure effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 8-18 years
2. BMI \> 85th centile
3. CAP \> 236

Exclusion Criteria:

\- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.

Where it's running

• Institute of Liver & Biliary Sciences
  New Delhi, National Capital Territory of Delhi, India Recruiting

Study contacts

• Study coordinator: Dr Ashray S Patel, MD
• Email: patel1995ash@gmail.com
• Phone: 01146300000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.