{"id":1812,"date":"2018-02-14T09:05:53","date_gmt":"2018-02-14T08:05:53","guid":{"rendered":"https:\/\/www.mivell.com\/sperimentazione-clinica-brumechol\/"},"modified":"2018-12-23T22:55:31","modified_gmt":"2018-12-23T21:55:31","slug":"brumechol-clinical-trial-start","status":"publish","type":"post","link":"https:\/\/www.mivell.com\/en\/brumechol-clinical-trial-start\/","title":{"rendered":"BrumeChol clinical trial is start"},"content":{"rendered":"<p>In the 21st of December 2017 session the INRCA ethical committee gave favorable opinion to the NO PROFIT clinical trial entitled: \u201c<strong>evaluation of the lipid-lowering effect of the nutritional supplement Brumechol in patients with slight hypercholesterolemia.<\/strong>\u201d<\/p>\n<p>The 14th of February 2018 the favorable opinion was published by the INRCA-IRCSS general direction that let the clinical trial start.<\/p>\n<h3>Purpose<\/h3>\n<p><strong>Verify the lipid-lowering effect of the nutritional supplement Brumechol on blood level of total cholesterol in patients with slight hypercholesterolemia.<\/strong><\/p>\n<h3>Design<\/h3>\n<p>Interventional, two arms randomized, duoble-blinded study versus placebo.<\/p>\n<h3>Outcomes<\/h3>\n<p><strong>Primary outcomes:<\/strong><br \/>\nReduction of total cholesterol blood level<br \/>\n<strong>Secondary outcomes:<\/strong><br \/>\nChange in circulating markers of inflammation (PCR, IL-6)<br \/>\nChange in the expression of specific circulating miRNA<br \/>\nLink between genetic polymorphisms and cardiovascular risk, lipid and inflammatory parameters evaluated at base-line (only for patient that gave the consensus for genetic exam)<br \/>\nLink between cardiovascular risk (evaluated as SCORE) and lipid and inflammatory parameters evaluated at base-line.<\/p>\n<h3>Sample size<\/h3>\n<p>In sample size evaluation has been token into account the main variable that is the change in total cholesterol level, an alpha error of 0.05, a medium effect size of 0.5 and a power superior of 85%.<br \/>\nThe study need 118 patients to have the possibility to obtain a statistical significance in a two tails test between the treatments, at least 59 patients for group. Expecting a drop-out of 5%, will be enrolled 125 participants. For the sample size calculation indipendent samples t-test was used.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the 21st of December 2017 session the INRCA ethical committee gave favorable opinion to the NO PROFIT clinical trial entitled: \u201cevaluation of the lipid-lowering effect of the nutritional supplement Brumechol in patients with slight hypercholesterolemia.\u201d The 14th of February 2018 the favorable opinion was published by the INRCA-IRCSS general direction that let the clinical trial start. Purpose Verify the lipid-lowering effect of the nutritional supplement Brumechol on blood level of total cholesterol in patients with slight hypercholesterolemia. Design Interventional, two arms randomized, duoble-blinded study versus placebo. Outcomes Primary outcomes: Reduction of total cholesterol blood level Secondary outcomes: Change in <\/p>\n","protected":false},"author":1,"featured_media":2216,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[69],"tags":[],"yst_prominent_words":[],"_links":{"self":[{"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/posts\/1812"}],"collection":[{"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/comments?post=1812"}],"version-history":[{"count":3,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/posts\/1812\/revisions"}],"predecessor-version":[{"id":1816,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/posts\/1812\/revisions\/1816"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/media\/2216"}],"wp:attachment":[{"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/media?parent=1812"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/categories?post=1812"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/tags?post=1812"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/www.mivell.com\/en\/wp-json\/wp\/v2\/yst_prominent_words?post=1812"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}