Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADF | Experimental | Experimental: Alternate day fasting, along with standard medical management. |
|
| Control arm | No Intervention | Standard medical management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate day fasting | Behavioral | Alternate day fasting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of NASH over a 24-week duration. | Histologically confirmed NASH, biochemical resolution. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criter
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Babu Lal Meena, DM Hepatology | Contact | +91-9781100898 | drbabupgi@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | Recruiting | Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36517002 | Background | Teng ML, Ng CH, Huang DQ, Chan KE, Tan DJ, Lim WH, Yang JD, Tan E, Muthiah MD. Global incidence and prevalence of nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S32-S42. doi: 10.3350/cmh.2022.0365. Epub 2022 Dec 14. | |
| 27837778 | Background | Carr RM, Oranu A, Khungar V. Nonalcoholic Fatty Liver Disease: Pathophysiology and Management. Gastroenterol Clin North Am. 2016 Dec;45(4):639-652. doi: 10.1016/j.gtc.2016.07.003. Epub 2016 Oct 13. |
Not provided
Not provided
Investigators currently do not plan to share individual participant data (IPD) from this study. The decision is based on considerations of patient privacy, confidentiality concerns, and the lack of a data-sharing infrastructure. While the aggregated study results will be published and made publicly available, sharing individual-level data could pose risks related to identifying participants. Therefore, IPD will not be shared beyond what is required for regulatory purposes.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Randomised controlled trial.
Not provided
Not provided
Not provided
Not provided
| Change from baseline to 24 weeks |
| Change in stage of fibrosis | Measured by fibroscan(LSM) | Change from baseline to 24 weeks |
| Weight | Change in weight at 1, 3, and 6 month of follow up. | Change from baseline to 24 weeks |
| Change in glycaemic status | Change in HbA1c level at baseline, 3 and 6 months. | Change from baseline to 24 weeks |
| Change in liver fat content | Measured by fibroscan(CAP) | Change from baseline to 24 weeks |
| Change in bone mineral density | As measured by dual-energy X ray absorptiometry (DEXA) scan | Change from baseline to 24 weeks |
| Change in faecal microbiota. | Stool analysis | Change from baseline to 24 weeks |
| Body mass index | Change in body mass index at 1, 3, and 6 month of follow up. | 24 weeks |
| Waist to hip ratio | Change in Waist to hip ratio at 1, 3, and 6 month of follow up. | 24 weeks |
| 22488764 | Background | Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available. |
| 37363821 | Background | Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24. |
| 32372515 | Background | Loomba R, Wong R, Fraysse J, Shreay S, Li S, Harrison S, Gordon SC. Nonalcoholic fatty liver disease progression rates to cirrhosis and progression of cirrhosis to decompensation and mortality: a real world analysis of Medicare data. Aliment Pharmacol Ther. 2020 Jun;51(11):1149-1159. doi: 10.1111/apt.15679. Epub 2020 May 5. |
| 36727674 | Background | Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available. |
| 20427778 | Background | Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28. |
| 19827166 | Background | Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276. |
| 34478753 | Background | van den Hoek AM, de Jong JCBC, Worms N, van Nieuwkoop A, Voskuilen M, Menke AL, Lek S, Caspers MPM, Verschuren L, Kleemann R. Diet and exercise reduce pre-existing NASH and fibrosis and have additional beneficial effects on the vasculature, adipose tissue and skeletal muscle via organ-crosstalk. Metabolism. 2021 Nov;124:154873. doi: 10.1016/j.metabol.2021.154873. Epub 2021 Sep 1. |
| 22213436 | Background | Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25. |
| 27188904 | Background | Yang W, Cao M, Mao X, Wei X, Li X, Chen G, Zhang J, Wang Z, Shi J, Huang H, Yao X, Liu C. Alternate-day fasting protects the livers of mice against high-fat diet-induced inflammation associated with the suppression of Toll-like receptor 4/nuclear factor kappaB signaling. Nutr Res. 2016 Jun;36(6):586-93. doi: 10.1016/j.nutres.2016.02.001. Epub 2016 Feb 16. |
| 36930148 | Background | Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513. |
| 31852444 | Background | Cai H, Qin YL, Shi ZY, Chen JH, Zeng MJ, Zhou W, Chen RQ, Chen ZY. Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial. BMC Gastroenterol. 2019 Dec 18;19(1):219. doi: 10.1186/s12876-019-1132-8. |
| 22608008 | Background | Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |