{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T02:50:21Z","timestamp":1794279021471,"version":"4.9.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T00:00:00Z","timestamp":1768003200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"content-version":"vor","delay-in-days":27,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Naturmega SA"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Complement Med Ther"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hypertriglyceridemia is a modifiable risk factor for cardiovascular disease, and while omega-3 fatty acids (omega-3 FAs) are known to lower triglyceride (TG) concentrations, their effectiveness is influenced by formulation and bioavailability. Phospholipid-bound (PL) omega-3 FAs\u2014such as those found in krill oil\u2014demonstrate superior intestinal absorption and membrane integration compared with TG- and ethyl ester omega-3 FAs based forms. Preclinical studies have shown that PL omega-3 FAs exhibit anti-inflammatory, antithrombotic, and TG-lowering properties; however, clinical data remain limited. This pilot randomized clinical trial compared the efficacy of PL omega-3 FAs with standard omega-3 FAs in patients with mild to moderate hypertriglyceridemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a randomized, controlled, double-blind, parallel-group pilot trial involving patients aged 18\u201365 years with fasting TG between 150 and 499\u00a0mg\/dL. Patients were randomized to receive PL omega-3 FAs (eicosapentaenoic acid [EPA)\u2009+\u2009docosahexaenoic acid [DHA), 825\u00a0mg\/day) or standard omega-3 FAs (EPA\u2009+\u2009DHA, 903\u00a0mg\/day). Primary outcomes were changes in fasting TG and omega-3 index (O3I) after 12 weeks. Secondary outcomes included changes in lipid profile, glycemic markers, inflammatory markers, anthropometric measures, hemodynamic variables, and safety parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 47 randomized participants, 44 (22 per group) completed the study and were included in the analysis. Mean TG levels decreased slightly in the PL group (-9.1\u00a0mg\/dL) and increased in the standard group (+\u200915.2\u00a0mg\/dL), with no statistically significant difference between-groups (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.416). Although the O3I increased significantly in both groups, the between-group difference was not statistically significant, despite a greater rise in the PL group (+\u20091.78% vs. +1.50%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.446). At week 12, 36.4% of participants in the PL group achieved TG\u2009\u2264\u2009150\u00a0mg\/dL, compared with 13.6% in the standard group (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.041). No serious adverse events were reported, and treatment adherence exceeded 95%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In summary, this pilot randomized trial did not demonstrate statistically significant differences between the PL and TG formulations in triglyceride or Omega-3 Index reduction. However, the numerically higher responder rate and favorable biochemical trends observed with the PL formulation warrant further investigation in larger, adequately powered studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      NCT06749028 (retrospectively registered on December 19, 2024, after enrollment of the first participant). Available at:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06749028\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/study\/NCT06749028<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>European Food Safety Authority (EFSA)<\/jats:title>\n                    <jats:p>EFSA-2024-00030369.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12906-026-05245-1","type":"journal-article","created":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T03:06:08Z","timestamp":1768014368000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy of phospholipid-bound omega-3 versus standard omega-3 in patients with hypertriglyceridemia: a randomized clinical trial"],"prefix":"10.1186","volume":"26","author":[{"given":"Miguel","family":"Urina-Triana","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Gabriel","family":"David-Pardo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Urina-Triana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jhesua","family":"Valencia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Bernal-Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Urina-Jassir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erick","family":"Orozco-Acosta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarec K.","family":"Elajami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,10]]},"reference":[{"issue":"20","key":"5245_CR1","doi-asserted-by":"publisher","first-page":"2292","DOI":"10.1161\/CIR.0b013e3182160726","volume":"123","author":"M \u2060 \u2060Miller","year":"2011","unstructured":"\u2060 \u2060Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, et al. 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The Ethics Committee classified the study as minimal risk and confirmed compliance with Colombian national regulations (Resolution No. 2378 of 2008), ICH-GCP guidelines, and international bioethics standards. All participants provided written informed consent before enrollment.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"48"}}