In the 21st of December 2017 session the INRCA ethical committee gave favorable opinion to the NO PROFIT clinical trial entitled: “evaluation of the lipid-lowering effect of the nutritional supplement Brumechol in patients with slight hypercholesterolemia.”
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 circulating markers of inflammation (PCR, IL-6)
Change in the expression of specific circulating miRNA
Link between genetic polymorphisms and cardiovascular risk, lipid and inflammatory parameters evaluated at base-line (only for patient that gave the consensus for genetic exam)
Link between cardiovascular risk (evaluated as SCORE) and lipid and inflammatory parameters evaluated at base-line.
Sample size
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%.
The 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.
