Non Alcoholic Steatohepatitis
Conditions
Keywords
Alternate day fasting., NASH, MASH, Steatotic liver disease, Cirrhosis
Brief 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.
Detailed 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.
Interventions
BEHAVIORALAlternate day fasting
Alternate day fasting
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of NASH over a 24-week duration. | 24 weeks | Histologically confirmed NASH, biochemical resolution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stage of fibrosis | Change from baseline to 24 weeks | Measured by fibroscan(LSM) |
| Weight | Change from baseline to 24 weeks | Change in weight at 1, 3, and 6 month of follow up. |
| Change in glycaemic status | Change from baseline to 24 weeks | Change in HbA1c level at baseline, 3 and 6 months. |
| Change in liver fat content | Change from baseline to 24 weeks | Measured by fibroscan(CAP) |
| Change in the quality of life index | Change from baseline to 24 weeks | 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 faecal microbiota. | Change from baseline to 24 weeks | Stool analysis |
| Body mass index | 24 weeks | Change in body mass index at 1, 3, and 6 month of follow up. |
| Waist to hip ratio | 24 weeks | Change in Waist to hip ratio at 1, 3, and 6 month of follow up. |
| Change in bone mineral density | Change from baseline to 24 weeks | As measured by dual-energy X ray absorptiometry (DEXA) scan |
Countries
India
Contacts
Primary ContactBabu Lal Meena, DM Hepatology
Outcome results
None listed