Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum
Abstract
Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-classes. This summary by the Liver Forum's Standard of Care Working Group reviews currently available clinical data, identifies the barriers and challenges associated with the standard of care in NAFLD/NASH clinical trials, defines available assessments of lifestyle changes, and proposes approaches to better understand and define the influence of diet and exercise on NASH treatment in the context of different pharmacologic interventions. The ultimate objective is to propose tangible solutions which enable investigators, sponsors, and regulatory authorities to meaningfully interpret clinical trial outcomes and the impact of lifestyle modification on such outcomes as they pertain to phase I-IV clinical trials.
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Current clinical trials, with most including intervention phase of 12 to 72 months, may not adequately detect changes in fibrosis.
“this bears the risk that current clinical trials, with most of them including an intervention phase of 12 to 72 months, may not adequately detect changes in fibrosis [238].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [238]
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Self-citation
- Authors
- Glass, O., Filozof, C., Noureddin, M., Berner-Hansen, M., Schabel, E., Omokaro, S. O., Schattenberg, J. M., Barradas, K., Miller, V., Francque, S., & Abdelmalek, M. F.
- Affiliations
- Duke University (US)
- Covance (United States) (US)
- Cedars-Sinai Medical Center (US)
- Bispebjerg Hospital (DK)
- Federal Institute for Drugs and Medical Devices (DE)
- United States Food and Drug Administration (US)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- University of California, Berkeley (US)
- University of Antwerp (BE)
- Corresponding author
- Francque, Sven
- Abdelmalek, Manal F.
- ORCID
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 2020-09
- Volume
- 73
- Issue
- 3
- Pages
- 680-693
- ISSN
- 0168-8278 (ISSN-L)
- OpenAlex
- W3020802882
- Cited by
- 89
- References
- 41
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 16 · 2023: 18 · 2022: 9 · 2021: 23 · 2020: 8
- FWCI
- 2.12
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- 3-V Biosciences
- Abbott Molecular
- AbbVie
- Advanced Biological Laboratories
- Afimmune
- Aicuris
- Allergan
- Aligos Therapeutics
- Altimmune
- AMRA Medical
- Arbutus Biopharma
- Arrowhead Pharmaceuticals
- Assembly Biosciences
- Astellas
- Astra-Zeneca
- Biogen
- Boehringer Ingelheim
- Bristol-Myers Squib
- Celgene
- Chimerix
- Cirius Therapeutics
- Cocrystal Pharma, Inc.
- Conatus Pharmaceuticals, Inc.
- ConSynance
- Covance
- DDL Diagnostics
- CTI Clinical Trial and Consulting Services
- Cirius Therapeutics Inc.
- ContraVir
- Cymabay
- DeuteRx
- DiaPharma
- DS Biopharma
- Durect
- EA Pharma Co., Ltd.
- Echosens
- Eli Lilly and Company
- Enanta Pharmaceuticals, Inc.
- Enyo Pharma
- e.scopics
- Exalenz
- Ferring Pharmaceuticals
- Fractyl
- Galectin Therapeutics
- Genentech
- Genesis Imaging Services
- Genfit
- Genkyotex
- Gilead Sciences
- GlaxoSmithKline
- Glympse Bio
- Hepatitis B Foundation
- HepQuant
- HighTide Therapeutics
- HistoIndex Pte Ltd
- Humedics GmbH
- ICON Clinical Research
- Immuron
- Intercept Pharmaceuticals
- Inventiva
- Ironwood Pharmaceuticals
- Janssen
- LabCorp
- Madrigal Pharmaceuticals
- Mallinckrodt Pharmaceuticals
- MEDIAN Technologies
- MediciNova
- Medivir
- Merck Laboratories
- Metacrine
- Microbiotix
- Mirum
- Morphic Therapeutic
- Mylan
- NGM Biopharmaceuticals
- Nimbus Therapeutics
- Nitto Denko Technical Corp
- Nordic Bioscience
- Northsea Therapeutics
- Novartis
- Novo Nordisk Inc.
- Nusirt
- OWL Metabolomics
- Perspectum Diagnostics
- Pfizer
- Pliant Therapeutics
- PPD Inc.
- ProSciento
- Quest Diagnostics
- Raptor Pharmaceuticals
- Resonance Health
- Resoundant
- Roche Molecular Systems
- Roivant Sciences
- RuiYi
- SeraCare
- Shire
- Springbank Pharma
- Somalogic
- Syneos Health
- Takeda
- TARGET PharmaSolutions
- Teva Pharmaceuticals
- ViiV Healthcare
- VLVBio
- Zafgen
- Zealand Pharma
- Duke Divisions of Gastroenterology
- Integrative Medicine
- NIH (U01DK061713)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Keywords
- non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, lifestyle modification, diet, physical activity, clinical trial endpoints, lifestyle assessment, pharmacological interventions, standard of care
- MeSH terms
- Diet, Healthy, Adult, Body Weight, Clinical Trials as Topic, Exercise Therapy, Humans, Exercise, Body Mass Index, Treatment Outcome, Waist Circumference, Non-alcoholic Fatty Liver Disease
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