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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a method called alternate-day fasting can help improve a liver condition known as Non-Alcoholic Steatohepatitis (NASH) more effectively than standard medical treatment alone. NASH is a serious liver disease that can lead to liver damage. The trial is currently looking for participants aged 18 to 65 who have a stable weight and specific liver health indicators. To join, individuals must have a body mass index (BMI) between 25 and 40 and must have been diagnosed with NASH.

If you qualify and decide to participate, you will be part of a study comparing the effects of alternate-day fasting with regular medical management. Participants will receive support and guidance throughout the study. It's important to know that individuals with more severe liver disease, certain other health issues, or those taking specific medications may not be eligible. This trial offers a chance to explore new ways to manage and potentially improve liver health.

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Eligibility 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