RecruitingNot ApplicableNCT06676813
Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.
Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis(NASH), A Randomized Controlled Trial. FAST Trial"
Sponsor
Institute of Liver and Biliary Sciences, India
Enrollment
72 participants
Start Date
Jul 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria14
- 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
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Interventions
BEHAVIORALAlternate day fasting
Alternate day fasting
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06676813