Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.

Institute of Liver and Biliary Sciences, India

Status

Enrolling

Conditions

Non Alcoholic Steatohepatitis

Treatments

Behavioral: Alternate day fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT06676813

12/8/2023-ACAD/E-12745/680

Details and patient eligibility

About

The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.

Full description

Emerging evidence suggests the role of alternate-day fasting (ADF) in patients with obesity and fatty liver. It helps to lose weight and improvement in liver fat content. ADF regimen protocol includes fast day(restricted calorie intake and time-specific feeding) and feast day(ad libitum feed over 24 hours). Lowering the weight and improvement of the fatty liver. NASH is a prevalent cause of liver disease. Literature is evident that ADF improves fatty liver and metabolic components, and NASH improves with weight loss. Still, data about the role of ADF in the management of NASH is lacking. Hence, this study focuses on the role of ADF in NASH.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Age 18-65 years. BMI 25-40kg/m3, and CAP more than 290
Stable weight in the last 3 months prior to enrolling in the study(<5kg weight variation)
Imaging showed steatotic liver disease, liver stiffness <14kPa measured by fibroscan
Histologically proven NASH/MASH, fibrosis up to F3
Subjects willing to participate in the study

Exclusion Criter

Liver stiffness >14kPa measured by fibroscan or Fibrosis >F3
Diabetes with HbA1c>8.5%
Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease
Patients with cirrhosis, hepatocellular carcinoma(HCC), or other malignancy
Chronic kidney disease, cardiovascular disorders, uncontrolled hypertension
Chronic infections, chronic inflammatory diseases
Patients on weight loss medications e.g semaglutide
Pregnant or lactating women and those planning a pregnancy A patient who is not willing to participate in the study or failed to provide the consent