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Role of different diets on hepatic steatosis and fibrosis in Overweight NAFLD children

Effect of Indo-Mediterranean diet on hepatic steatosis and fibrosis in Overweight children and adolescent with Biopsy proven NAFLD: A Randomised Control trial - NAFLD Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036897
Enrollment
32
Registered
2021-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Indo Mediterrenean diet: Indian version of Mediterranean diet will be given to NAFLD children for 180 days Control Intervention1: Calorie restricted diet: Diet restricted in calories (a

Sponsors

Institute of liver and biliary sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age 8-18 years • BMI > 85th centile • USG s/o Fatty Liver • Biopsy proven NAFLD

Exclusion criteria

Exclusion criteria: • Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease • Liver Biopsy not done • Refused Consent

Design outcomes

Primary

MeasureTime frame
The Primary outcome measure will be a composite end point defined by decrease in CAP and ALT values by 10% from baseline and decrease in PNFI score to less than 3Timepoint: 180 days

Secondary

MeasureTime frame
Lipid Profile (Time frame : Change in Cholesterol, triglycerides of atleast 10% from baseline at 180 days) Lipid profile will be measured in a fasting state Timepoint: 180 days;Weight (Time frame : Change in Weight of atleast 7% from baseline at 180 days) Weight will be recorded at the baseline and at the completion of diet intervention Timepoint: 180 days

Countries

India

Contacts

Public ContactAniket Deshmukh

Institute of Liver and biliary sciences, Delhi

seema_alam@hotmail.com

Outcome results

None listed

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