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Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial).
J Am Heart Assoc 2015; 4(8):e002034JA

Abstract

BACKGROUND

Patients with peripheral artery disease (PAD) experience significant morbidity and mortality. The OMEGA-PAD I Trial, a randomized, double-blinded, placebo-controlled trial, addressed the hypothesis that short-duration, high-dose n-3 polyunsaturated fatty acids (n-3 PUFA) oral supplementation improves endothelial function and inflammation in PAD.

METHODS AND RESULTS

Eighty patients with stable claudication received 4.4 g of fish oil or placebo for 1 month. The primary end point was endothelial function as measured by brachial artery flow-mediated vasodilation. Secondary end points included biomarkers of inflammation, n-3 polyunsaturated fatty acids metabolome changes, lipid profile, and walking impairment questionnaires. Although there was a significant increase in FMD in the fish oil group following treatment (0.7±1.8% increase from baseline, P=0.04), this response was not different then the placebo group (0.6±2.5% increase from baseline, P=0.18; between-group P=0.86) leading to a negative finding for the primary endpoint. There was, however, a significant reduction in triglycerides (fish oil: -34±46 mg/dL, P<0.001; placebo -10±43 mg/dL, P=0.20; between-group differential P-value: 0.02), and an increase in the omega-3 index of 4±1% (P<0.001) in the fish oil group (placebo 0.1±0.9%, P=0.49; between-group P<0.0001). We observed a significant increase in the production of pathway markers of specialized pro-resolving mediators generated from n-3 polyunsaturated fatty acids in the fish oil group.

CONCLUSIONS

High-dose, short-duration fish oil supplementation did not lead to a different response in the primary end point of endothelial function between the treatment and placebo group, but improved serum triglycerides and increased the production of downstream n-3 polyunsaturated fatty acids-derived products and mediators in patients with PAD.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01310270.

Authors+Show Affiliations

Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.) Department of Surgery, Veterans Affairs Medical Center, San Francisco, CA (M.G., C.D.O., M.H.F., S.P.) Vascular Integrated Physiology and Experimental Therapeutics (VIPERx) Lab, San Francisco, CA (M.G., C.D.O., H.F.A., K.C., S.P.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.) Department of Surgery, Veterans Affairs Medical Center, San Francisco, CA (M.G., C.D.O., M.H.F., S.P.) Vascular Integrated Physiology and Experimental Therapeutics (VIPERx) Lab, San Francisco, CA (M.G., C.D.O., H.F.A., K.C., S.P.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.) Department of Surgery, Veterans Affairs Medical Center, San Francisco, CA (M.G., C.D.O., M.H.F., S.P.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.) Vascular Integrated Physiology and Experimental Therapeutics (VIPERx) Lab, San Francisco, CA (M.G., C.D.O., H.F.A., K.C., S.P.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.) Vascular Integrated Physiology and Experimental Therapeutics (VIPERx) Lab, San Francisco, CA (M.G., C.D.O., H.F.A., K.C., S.P.).Department of Surgery, Veterans Affairs Medical Center, San Francisco, CA (M.G., C.D.O., M.H.F., S.P.) Vascular Integrated Physiology and Experimental Therapeutics (VIPERx) Lab, San Francisco, CA (M.G., C.D.O., H.F.A., K.C., S.P.).Department of Biostatistics, University of California Los Angeles, Los Angeles, CA (P.K.Y.).Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA (J.B.).Center for Experimental Therapeutics and Reperfusion Injury, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (J.H., M.S.).Center for Experimental Therapeutics and Reperfusion Injury, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (J.H., M.S.).Department of Surgery, University of California, San Francisco, San Francisco, CA (M.G., C.D.O., E.V.N., M.H.F., H.F.A., K.C., M.S.C.).

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26296857

Citation

Grenon, S Marlene, et al. "Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial)." Journal of the American Heart Association, vol. 4, no. 8, 2015, pp. e002034.
Grenon SM, Owens CD, Nosova EV, et al. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015;4(8):e002034.
Grenon, S. M., Owens, C. D., Nosova, E. V., Hughes-Fulford, M., Alley, H. F., Chong, K., ... Conte, M. S. (2015). Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). Journal of the American Heart Association, 4(8), pp. e002034. doi:10.1161/JAHA.115.002034.
Grenon SM, et al. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. PubMed PMID: 26296857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). AU - Grenon,S Marlene, AU - Owens,Christopher D, AU - Nosova,Emily V, AU - Hughes-Fulford,Millie, AU - Alley,Hugh F, AU - Chong,Karen, AU - Perez,Sandra, AU - Yen,Priscilla K, AU - Boscardin,John, AU - Hellmann,Jason, AU - Spite,Matthew, AU - Conte,Michael S, Y1 - 2015/08/21/ PY - 2015/8/23/entrez PY - 2015/8/25/pubmed PY - 2016/5/5/medline KW - fish oil KW - n‐3 polyunsaturated fatty acids KW - peripheral artery disease KW - specialized pro‐resolving mediators KW - vascular function SP - e002034 EP - e002034 JF - Journal of the American Heart Association JO - J Am Heart Assoc VL - 4 IS - 8 N2 - BACKGROUND: Patients with peripheral artery disease (PAD) experience significant morbidity and mortality. The OMEGA-PAD I Trial, a randomized, double-blinded, placebo-controlled trial, addressed the hypothesis that short-duration, high-dose n-3 polyunsaturated fatty acids (n-3 PUFA) oral supplementation improves endothelial function and inflammation in PAD. METHODS AND RESULTS: Eighty patients with stable claudication received 4.4 g of fish oil or placebo for 1 month. The primary end point was endothelial function as measured by brachial artery flow-mediated vasodilation. Secondary end points included biomarkers of inflammation, n-3 polyunsaturated fatty acids metabolome changes, lipid profile, and walking impairment questionnaires. Although there was a significant increase in FMD in the fish oil group following treatment (0.7±1.8% increase from baseline, P=0.04), this response was not different then the placebo group (0.6±2.5% increase from baseline, P=0.18; between-group P=0.86) leading to a negative finding for the primary endpoint. There was, however, a significant reduction in triglycerides (fish oil: -34±46 mg/dL, P<0.001; placebo -10±43 mg/dL, P=0.20; between-group differential P-value: 0.02), and an increase in the omega-3 index of 4±1% (P<0.001) in the fish oil group (placebo 0.1±0.9%, P=0.49; between-group P<0.0001). We observed a significant increase in the production of pathway markers of specialized pro-resolving mediators generated from n-3 polyunsaturated fatty acids in the fish oil group. CONCLUSIONS: High-dose, short-duration fish oil supplementation did not lead to a different response in the primary end point of endothelial function between the treatment and placebo group, but improved serum triglycerides and increased the production of downstream n-3 polyunsaturated fatty acids-derived products and mediators in patients with PAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01310270. SN - 2047-9980 UR - https://www.unboundmedicine.com/medline/citation/26296857/Short_Term_High_Dose_Fish_Oil_Supplementation_Increases_the_Production_of_Omega_3_Fatty_Acid_Derived_Mediators_in_Patients_With_Peripheral_Artery_Disease__the_OMEGA_PAD_I_Trial__ L2 - http://www.ahajournals.org/doi/full/10.1161/JAHA.115.002034?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -