Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial
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Background & aims This study's aim was to assess the histological and metabolic effects of n-3 polyunsaturated fatty acids (PUFAs) vs. placebo while adjusting for the impact of age and weight change in NASH patients. (ClinicalTrials.gov: NCT00681408).Methods Forty-one subjects with non-cirrhotic NASH were enrolled, and 34 completed the study. 17 received n-3 fish oil 3000 mg/day and 17 received placebo daily for 1 year with typical counselling on caloric intake and physical activity for all subjects.Results N-3- and placebo-treated groups showed no significant difference for the primary end point of NASH activity score (NAS) reduction ⩾ 2 points without fibrosis progression after adjustment for known covariates (n-3, 4/17 (23.5%); placebo, 3/17, (17.6%), p = 0.99). Among subjects with increased or stable weight, n-3 subjects showed a larger decrease in liver fat content by MRI than placebo-treated subjects (p = 0.014 for 2nd quartile, p = 0.003 for 3rd quartile of weight change). N-3 treatment showed significant fat reduction on the paired analysis of image-assisted fat morphometry regardless of weight loss or gain. Exercise capacity remained markedly reduced in all subjects. No independent effects on markers of hepatocyte injury or insulin sensitivity indices were observed.Conclusion N-3 PUFAs at 3000 mg/day for one year did not lead to an improvement in the primary outcome of histological activity in NASH patients (⩾ 2 point NAS reduction). N-3 led to reduced liver fat by multiple measures. Other metabolic effects were not seen, although no detrimental effects were apparent. Whether longer duration, higher dose, or different composition of n-3 therapy would lead to additional benefits is uncertain.
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Supplementation with eicosapentaenoic acid (in ethyl ester formulation) did not show any histological efficacy vs. placebo in RCTs.
“However, supplementation with eicosapentaenoic acid (in ethyl ester formulation) did not show any histological ef fi cacy vs . placebo in RCTs.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [387]
The Discussion reports that one placebo-controlled EPA-only trial found no significant difference in histological measures; the cited trial’s title identifies the agent as ethyl-eicosapentaenoic acid (Reference 38). But this paper’s own RCT used a triglyceride-formulated EPA/DHA mixture (Methods, Active Drug Therapy), so it does not establish the claim for ethyl-ester EPA across multiple RCTs. (LLM, conf=0.84)
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- Authors
- Argo, C. K., Patrie, J. T., Lackner, C., Henry, T. D., de Lange, E. E., Weltman, A. L., Shah, N. L., Al-Osaimi, A. M., Pramoonjago, P., Jayakumar, S., Binder, L. P., Simmons-Egolf, W. D., Burks, S. G., Bao, Y., Taylor, A. G., Rodriguez, J., & Caldwell, S. H.
- Affiliations
- University of Virginia Health System (US)
- University of Virginia (US)
- Medical University of Graz (AT)
- University of Calgary (CA)
- Corresponding author
- Argo, Curtis K.
- Caldwell, Stephen H.
- ORCID
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 2015-01
- Volume
- 62
- Issue
- 1
- Pages
- 190-197
- ISSN
- 0168-8278 (ISSN-L)
- PMC
- PMC4272639
- OpenAlex
- W2019810874
- Cited by
- 224
- References
- 37
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 17 · 2023: 21 · 2022: 13 · 2021: 21 · 2020: 17 · 2019: 16 · 2018: 30 · 2017: 24 · 2016: 19 · 2015: 21 · 2014: 1
- FWCI
- 16.41
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Hepatology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- University of Virginia
- National Center for Research Resources (5 M01 RR00847, M01RR000847)
- National Center for Complementary and Integrative Health (R21AT002901, 5R21AT2901-2)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Keywords
- omega-3 polyunsaturated fatty acids, nonalcoholic steatohepatitis, liver fat, weight change, exercise capacity, insulin sensitivity, hepatocyte injury, non-cirrhotic liver disease
- MeSH terms
- Adult, Aged, Biopsy, Double-Blind Method, Energy Metabolism, Female, Follow-Up Studies, Humans, Liver, Male, Middle Aged, Retrospective Studies, Fatty Acids, Omega-3, Non-alcoholic Fatty Liver Disease
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