The Efficacy of a Food Supplement Consisting of the Combination of an Olive Extract and a Myrtle Extract for the Improvement of Lipid Metabolism in Subjects With Slightly Altered Cholesterolemia Values

Study Objective The aim of the study is to evaluate the efficacy of a dietary supplement based on a mixture of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts in maintaining normal plasma cholesterol levels in subjects with mildly altered (borderline) cholesterol levels. Study Design A single-center, randomized, controlled, two-arm, double-blind, parallel-group clinical trial will be conducted, including a 15-day run-in period. The treatment period will last 3 months, during which subjects will receive either the dietary supplement or a placebo. This duration is considered adequate by EFSA to evaluate the clinical efficacy of commonly consumed food components or dietary supplements on hypercholesterolemia. Before starting the treatment period, enrolled subjects will undergo a 15-day run-in phase during which they will not receive any treatment but will be required to complete a daily food diary. Experimental Groups Group 1 (56 subjects): Participants will take one capsule per day of a dietary supplement consisting of a blend of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts. Group 2 (56 subjects): Participants will receive a placebo\*. To control for variables that could bias the interpretation of results, participants will be instructed to: Follow an isocaloric diet for the entire duration of the study, as specified in the protocol, and record it in a food diary. Report all pharmacological treatments at each visit. \*Masking methods are described in the dedicated section. Each subject in both experimental groups will be monitored before, during, and after administration of the dietary supplement or placebo. Inclusion Criteria The study will include subjects of both sexes who meet the following criteria: Age between 18 and 70 years Ability to understand and sign informed consent Negative HIV test Negative pregnancy test Borderline total cholesterol levels (200-239 mg/dL, according to t