Effect of Indo-mediterranean diet on fatty liver

To compare the effect of Indo-Mediterranean Diet with continuous energy restriction diet on hepatic steatosis and fibrosis, body composition, and metabolic parameters in adults with non-alcoholic fatty liver disease - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071921

Enrollment

150

Registered

2024-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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 Mediterranean diet (IMD) GROUP: One arm consists of subjects who will be put on an IMD diet. In this diet, energy is provided as required by an individual based on ideal body weigh

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-60 years will be included. 2. Patients enrolled in the study need to be diagnosed with non-alcoholic fatty liver disease. 3. Patients should have a Body Mass Index (BMI) of = 25 kg/m2. 4. Adult patients will be willing to participate and ensure cooperation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing the treatment or recently diagnosed diabetes mellitus. 2. Participants who have undergone any recent (in the last three months) major surgery. 3. Patients with any acute or chronic infectious illness are excluded. 4. Patients with a history of pancreatitis or other diseases who require any dietary modifications/restrictions. 5. Patients with chronic heart and kidney disease and advanced end-organ damage are excluded from the study. 6. Patients who have chronic hepatitis are excluded. 7. Any Pregnant and lactating women are excluded from the study. 8. Presence of seropositivity for Hepatitis B, C, and Human Immunodeficiency Virus (HIV) patients are excluded. 9. Patients who consume excessive alcohol ( >20 g/day for women and >30 g/day for men). 10. Currently (in the last three months) enrolled or have been a part of any other intervention program study are excluded.

Design outcomes

Primary

Measure	Time frame
Improvement in Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), body weight, body composition, and metabolic parameters in NAFLD patientsTimepoint: Changes in CAP, Liver Stiffness Measurement (LSM), and metabolic parameters in NAFLD patients	—

Secondary

Measure	Time frame
The secondary outcome is to assess the improvement in biomarkers, energy expenditure, sleep quality, any subclinical inflammation, & quality of life. It also include the assessment of adherence to the dietary regime provided in the study.Timepoint: BASELINE, 6 WEEKS (1.5 months), 12 WEEKS (3 months)	—

Countries

India

Contacts

Public ContactDr. Naval K Vikram

ALL INDIA INSTUTUTE OF MEDICAL SCIENCES,NEW DELHI

navalvikram@gmail.com01126593678

Outcome results

None listed

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