Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.

NCT06676813 | Recruiting DMC

• 1 other identifier: 12/8/2023-ACAD/E-12745/680
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Steatohepatitis

Keywords

Alternate day fasting.; NASH; MASH; Steatotic liver disease; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change of NASH over a 24-week duration.

  Histologically confirmed NASH, biochemical resolution.

  24 weeks

Secondary Outcomes (9)

• Change in the quality of life index

  Change from baseline to 24 weeks

• Change in stage of fibrosis

  Change from baseline to 24 weeks

• Weight

  Change from baseline to 24 weeks

• Change in glycaemic status

  Change from baseline to 24 weeks

• Change in liver fat content

  Change from baseline to 24 weeks

Study Arms (2)

ADF

EXPERIMENTAL

Experimental: Alternate day fasting, along with standard medical management.

Behavioral: Alternate day fasting

Control arm

NO INTERVENTION

Standard medical management.

Interventions

Alternate day fasting BEHAVIORAL

Alternate day fasting

ADF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

Delhi, 110070, India

RECRUITING

Related Publications (14)

• 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.

  PMID: 36517002 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.

  PMID: 27837778 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.

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• 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.

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• 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.

  PMID: 32372515 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.

  PMID: 36727674 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.

  PMID: 20427778 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.

  PMID: 19827166 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.

  PMID: 34478753 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.

  PMID: 22213436 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.

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• 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.

  PMID: 36930148 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.

  PMID: 31852444 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.

  PMID: 22608008 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Babu Lal Meena, DM Hepatology

CONTACT

+91-9781100898; drbabupgi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial.

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: November 6, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)