About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Alternate day fasting
BehavioralAlternate day fasting
Treatment groups
Trial outcomes
Primary outcomes
Change of NASH over a 24-week duration.
Histologically confirmed NASH, biochemical resolution.
Secondary outcomes
Change in the quality of life index
The investigators will assess the CLDQ-NASH score (Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis), which comprises 29 items rated on a scale from 1 to 7. Each item score reflects the patient's experience, with 1 indicating the worst and 7 indicating the best quality of life. The average score across all 29 items provides an overall quality of life result: * 1 to 3: Indicates a poor quality of life, with significant symptom burden and substantial impact on daily activities. * 4 to 5: Suggests a moderate quality of life, where symptoms are present but manageable, with some limitations in daily activities. * 6 to 7: Reflects a high quality of life, with minimal symptoms and few or no limitations on daily life.
Change in stage of fibrosis
Measured by fibroscan(LSM)
Weight
Change in weight at 1, 3, and 6 month of follow up.
Change in glycaemic status
Change in HbA1c level at baseline, 3 and 6 months.
Sponsors and contacts
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