Effect of Indian Hepatoprotective Diet (IHPD) on hepatic steatosis, features of metabolic syndrome in patients with NAFLD and healthy individuals on a Western diet.

Effects of Indian Foods and Ayurvedic drugs on healthy and diseased liver; Effect of Indian hepatoprotective diet in reversibility of NAFLD. - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083070

Enrollment

120

Registered

2025-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Indian Hepatoprotective Diet: The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 25 Kcal/Kg BW/day, with a protein int

it is a parallel group under the same study).: Desserts/Sweets,Processed meats,Red Meats,Highly processed foods,Dairy products includes high fat ,refined grains,potato,wholegrains,vegetables,legumes,f

Eligibility

Inclusion criteria

Inclusion criteria: 1.Recently diagnosed (less than 3 months) consenting adults with NAFL (steatotosis) of grades 2 and 3 diagnosed on the basis of liver transient eleastography (controlled attenuation parameter: CAP more than 250) 2.BMI more than18 3.Age 18 to 55 years

Exclusion criteria

Exclusion criteria: 1.Intake of antibiotics within last month 2.Viral hepatitis 3.Significant alcohol consumption (regular consumption of more than 10g per day for females and more than 20g per day in males) 4.Chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded. 6.Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months 7.Seriously ill and bed ridden patients 8.Pregnant & lactating women

Design outcomes

Primary

Measure	Time frame
To study the effectiveness of IHPD on hepatic steatosis in patients with NAFLD and healthy individuals on Western diet.Timepoint: pre post (28 days)	—

Secondary

Measure	Time frame
To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in reducing body weight in patients with NAFLD and healthy individuals on Western diet in 28 days.Timepoint: pre post (28 days);To study the effectiveness of IHPD on features of metabolic syndrome i.e. Hyperglycemia (Fasting blood sugar, HbA1c levels, central obesity (waist circumference, visceral fat), hypertension (BP), and hypertriglyceridemia (serum triglyceride and HDL cholesterol levels) in patients with NAFLDTimepoint: pre post (28 days);To study the effectiveness of IHPD on gut microbiota in patients with NAFLD and healthy individuals on Western diet.Timepoint: pre post (28 days)	—

Measure

Time frame

To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in reducing body weight in patients with NAFLD and healthy individuals on Western diet in 28 days.Timepoint: pre post (28 days);To study the effectiveness of IHPD on features of metabolic syndrome i.e. Hyperglycemia (Fasting blood sugar, HbA1c levels, central obesity (waist circumference, visceral fat), hypertension (BP), and hypertriglyceridemia (serum triglyceride and HDL cholesterol levels) in patients with NAFLDTimepoint: pre post (28 days);To study the effectiveness of IHPD on gut microbiota in patients with NAFLD and healthy individuals on Western diet.Timepoint: pre post (28 days)

—

Countries

India

Contacts

Public ContactDr S K Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

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