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

Last updated: November 5, 2024
Sponsor: Institute of Liver and Biliary Sciences, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Treatment

Alternate day fasting

Clinical Study ID

NCT06676813
12/8/2023-ACAD/E-12745/680
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Alternate day fasting
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Institute of Liver and Biliary Sciences

    Delhi, 110070
    India

    Active - Recruiting

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