Using alternate day fasting to treat 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"
This study is testing if alternate-day fasting can help people with fatty liver disease feel better and improve their health compared to regular medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (Delhi) |
| Trial ID | NCT06676813 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of alternate-day fasting (ADF) compared to standard medical management in reversing non-alcoholic steatohepatitis (NASH). Participants will follow a regimen that includes fasting days with restricted calorie intake and feast days with ad libitum feeding. The study focuses on the potential benefits of ADF in reducing liver fat content and improving metabolic health in individuals with obesity and fatty liver disease. By examining the impact of ADF on NASH, the study seeks to fill a gap in current literature regarding dietary interventions for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI between 25-40 and histologically proven NASH with fibrosis up to F3.
Not a fit: Patients with advanced liver disease, significant comorbidities, or those on weight loss medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention for patients with NASH, potentially leading to improved liver health and weight management.
How similar studies have performed: While there is emerging evidence supporting the benefits of alternate-day fasting for fatty liver, this specific application in NASH management is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Delhi
- Institute of Liver and Biliary Sciences — Delhi, India (Recruiting)
Study contacts
- Study coordinator: Babu Lal Meena, DM Hepatology
- Email: drbabupgi@gmail.com
- Phone: +91-9781100898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.