Indian-style Mediterranean diet versus low-fat diet to reduce liver fat in overweight children with MASLD
Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial
This project will try to see if an Indianized Mediterranean diet or a low-fat diet better reduces liver fat in overweight children and teens with MASLD over 180 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06768216 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Overweight children and adolescents aged 8–18 years with BMI >85th percentile and CAP >236 dB/m who can commit to dietary counseling and clinic visits are ideal candidates.
Not a fit: Children with other liver diseases (for example viral hepatitis, autoimmune hepatitis, or Wilson disease) or those unable to follow dietary changes or attend follow-up visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the Indianized Mediterranean diet could reduce liver fat and improve metabolic and inflammatory markers in overweight children with MASLD.
How similar studies have performed: Mediterranean-style diets have reduced liver fat and improved metabolic markers in adults, but randomized data comparing these diets in children are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.