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Ensayo controlado aleatorizado2015

Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial

Argo CK, Patrie JT, Lackner C, Henry TD, de Lange EE, Weltman AL, Shah NL, Al-Osaimi AM, Pramoonjago P, Jayakumar S, Binder LP, Simmons-Egolf WD, Burks SG, Bao Y, Taylor AG, Rodriguez J, Caldwell SH

Journal of hepatology · 184 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Universidad u hospital
University of Virginia
Gobierno
National Center for Research Resources
Gobierno
National Center for Complementary and Integrative Health
Gobierno
NCCIH NIH HHS
Gobierno
NCRR NIH HHS
Subvenciones
National Center for Research Resources (M01RR000847); National Center for Complementary and Integrative Health (5R21AT2901-2); National Center for Research Resources (5 M01 RR00847); National Center for Complementary and Integrative Health (R21 AT002901)

Según 5 financiadores declarados.

Publicación

Publicado
2014-09-06 · J Hepatol · vol. 62 · número 1 · págs. 190–197
Editorial
Elsevier BV
Citado
224 citas · más que el 99% de estudios similares · 14.6× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
37 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Liver Disease Diagnosis and Treatment · Fatty Acid Research and Health · Alcohol Consumption and Health Effects
Palabras clave
omega-3 polyunsaturated fatty acids, nonalcoholic steatohepatitis, liver fat, weight change, exercise capacity, insulin sensitivity, hepatocyte injury, non-cirrhotic liver disease
MeSH
liver, humans, fatty acids, omega-3, biopsy, retrospective studies, follow-up studies, double-blind method, energy metabolism, adult, aged, middle aged, female, male, non-alcoholic fatty liver disease

17 autores

  • Curtis Kent Argo🇺🇸 · autor de correspondenciaUniversity of Virginia Health System; University of Virginia Medical Center
  • James T. Patrie🇺🇸University of Virginia
  • Carolin Lackner🇦🇹Medical University of Graz
  • Thomas D. Henry🇺🇸University of Virginia Health System
  • Eduard E. de Lange🇺🇸University of Virginia Health System
  • ARTHUR L. WELTMAN🇺🇸University of Virginia
  • Neeral L. Shah🇺🇸University of Virginia Health System
  • Abdullah M. S. Al‐Osaimi🇺🇸University of Virginia Health System
  • Patcharin Pramoonjago🇺🇸University of Virginia Health System
  • Saumya Jayakumar🇨🇦🇺🇸University of Calgary; University of Virginia Health System
  • Lukas Binder🇦🇹Medical University of Graz
  • Winsor D. Simmons-Egolf🇺🇸University of Virginia Health System
  • Sandra G. Burks🇺🇸University of Virginia Health System
  • Yongde Bao🇺🇸University of Virginia
  • Ann Gill Taylor🇺🇸University of Virginia
  • Jessica Rodriguez🇺🇸University of Virginia
  • Stephen Hugh Caldwell🇺🇸 · autor de correspondenciaUniversity of Virginia Health System; University of Virginia Medical Center

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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