Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Alternate day fasting with SMT: Fasting protocol in the intervention arm.
Intervention2: Standard medical management: SMT only.
Intervention3: Alternate day fasting with SMT in the inte
Sponsors
Intitute of Liver and BIliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: NASH patients, 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(less than 5kg weight variation). Imaging showed steatotic liver disease, liver stiffness less than 14kPa measured by fibroscan. Histologically proven NASH/MASH, fibrosis up to F3. Subjects willing to participate in the study
Exclusion criteria
Exclusion criteria: Liver stiffness more than 14kPa measured by fibroscan or Fibrosis more than F3. Diabetes with HbA1c more than 8.5%. Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease. Patients with cirrhosis, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is a reversal of NASH over a 24-week duration.Timepoint: 24weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Improvement in the quality of life index b. Reversal of stage of fibrosis c. No progression of fibrosis d. Reversal of fat content e. Quality of life: cardiorespiratory performance f. Anthropometry g. Improvement in glycaemic status h. Decreased liver fat content as measured by fibroscan i. Change in bone mineral density as measured by DEXA scan j. Change in faecal microbiota.Timepoint: 1, 3 6 months | — |
Countries
India
Contacts
Public ContactBabu Lal Meena
Institite of Liver and Biliary Sciences
Outcome results
None listed