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Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial.
J Hepatol 2015; 62(1):190-7JH

Abstract

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.

Authors+Show Affiliations

Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA. Electronic address: cka3d@virginia.edu.Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.Institute of Pathology, Medical University of Graz, Graz, Austria.Department of Radiology, University of Virginia Health System, Charlottesville, VA, USA.Department of Radiology, University of Virginia Health System, Charlottesville, VA, USA.Department of Exercise Physiology, University of Virginia, Charlottesville, VA, USA.Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.Department of Pathology, University of Virginia Health System, Charlottesville, VA, USA.Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA; Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada.Institute of Pathology, Medical University of Graz, Graz, Austria.Surgical Therapeutic Advancement Center, University of Virginia Health System, Charlottesville, VA, USA.Surgical Therapeutic Advancement Center, University of Virginia Health System, Charlottesville, VA, USA.Biomolecular Research Facility, School of Medicine, University of Virginia, Charlottesville, VA, USA.Center for the Study of Complementary and Alternative Therapies, University of Virginia, Charlottesville, VA, USA.Clinical Research Unit, Metabolic Research Kitchen, University of Virginia, Charlottesville, VA, USA.Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA. Electronic address: shc5c@virginia.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

25195547

Citation

Argo, Curtis K., et al. "Effects of N-3 Fish Oil On Metabolic and Histological Parameters in NASH: a Double-blind, Randomized, Placebo-controlled Trial." Journal of Hepatology, vol. 62, no. 1, 2015, pp. 190-7.
Argo CK, Patrie JT, Lackner C, et al. Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol. 2015;62(1):190-7.
Argo, C. K., Patrie, J. T., Lackner, C., Henry, T. D., de Lange, E. E., Weltman, A. L., ... Caldwell, S. H. (2015). Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. Journal of Hepatology, 62(1), pp. 190-7. doi:10.1016/j.jhep.2014.08.036.
Argo CK, et al. Effects of N-3 Fish Oil On Metabolic and Histological Parameters in NASH: a Double-blind, Randomized, Placebo-controlled Trial. J Hepatol. 2015;62(1):190-7. PubMed PMID: 25195547.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. AU - Argo,Curtis K, AU - Patrie,James T, AU - Lackner,Carolin, AU - Henry,Thomas D, AU - de Lange,Eduard E, AU - Weltman,Arthur L, AU - Shah,Neeral L, AU - Al-Osaimi,Abdullah M, AU - Pramoonjago,Patcharin, AU - Jayakumar,Saumya, AU - Binder,Lukas P, AU - Simmons-Egolf,Winsor D, AU - Burks,Sandra G, AU - Bao,Yongde, AU - Taylor,Ann Gill, AU - Rodriguez,Jessica, AU - Caldwell,Stephen H, Y1 - 2014/09/06/ PY - 2013/11/14/received PY - 2014/08/11/revised PY - 2014/08/26/accepted PY - 2014/9/9/entrez PY - 2014/9/10/pubmed PY - 2016/2/26/medline KW - Cardiorespiratory fitness KW - Exercise KW - Fatty liver KW - N-3 fatty acid KW - Obesity KW - Steatohepatitis SP - 190 EP - 7 JF - Journal of hepatology JO - J. Hepatol. VL - 62 IS - 1 N2 - 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. SN - 1600-0641 UR - https://www.unboundmedicine.com/medline/citation/25195547/Effects_of_n_3_fish_oil_on_metabolic_and_histological_parameters_in_NASH:_a_double_blind_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8278(14)00624-2 DB - PRIME DP - Unbound Medicine ER -