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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

Sponsor: Labomar SPA

Summary

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 the National Institutes of Health definition) LDL cholesterol levels \<159 mg/dL Not taking any medications and willing to avoid medication throughout the study period Mildly altered LDL cholesterol levels (100-159 mg/dL), according to NCEP guidelines: Optimal: \<100 mg/dL Near optimal/above optimal: 100-129 mg/dL Borderline high: 130-159 mg/dL High: 160-189 mg/dL Very high: ≥190 mg/dL Exclusion Criteria Subjects will be excluded if they meet any of the following conditions: Age \<18 or \>70 years High cardiovascular risk based on eight risk factors (sex, age, diabetes, smoking status, systolic blood pressure, total cholesterol, HDL cholesterol, antihypertensive treatment) according to the Italian National Institute of Health "Progetto Cuore" parameters Ongoing pharmacological treatment for hypercholesterolemia and/or hyperglycemia, even at low doses Use of supplements for cholesterol, glycemia, or metabolic syndrome within two weeks prior to enrollment Pregnant women, suspected pregnancy, or planning pregnancy Breastfeeding women Blood donors within the three months prior to enrollment Non-self-sufficient individuals Subjects unwilling to cooperate Subjects unable to attend scheduled visits Subjects deemed unsuitable by the investigator due to other conditions requiring pharmacological treatment Subjects with HIV-related immunodeficiency Known allergies to the study product ingredients Alcohol consumption exceeding 30 g/day for men or 20 g/day for women Use of drugs of abuse Subjects currently taking medications

Official title: Efficacy Study of the Supplementation of a Food Supplement Consisting of the Combination of an Olive Extract (Olea Europea L., Fruit), and Myrtle Extract (Myrtus Communis L. Leaves) for the Improvement of Lipid Metabolism in Subjects Eith Slightly Altered Cholesterolemia Values: Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Study

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