Study of the efficacy of supplementation with a mixture of red fermented rice (monacolin K), gamma-oryzanol from rice bran (Oryza sativa L.), and gamma-aminobutyric acid for the maintenance of normal cardiovascular function in subjects with mildly altered cholesterolemia: single-center, controlled, randomized, parallel-arm, double-blind clinical study with run-in period

Istituto Nazionale Biostrutture e Biosistemi0 个研究点目标入组 88 人开始时间: 2023年11月29日最近更新: 2023年12月12日

试验速览

暂无简介。

•1. Aged < 18 and > 70 years;
•2. Who have a medical history or condition that could affect the subject's safety or negatively impact the validity of the study results;
•3. Pregnant or breastfeeding women;
•4. With history of allergy to ingredients contained in the study treatments (dietary supplement and placebo);
•5. Exposed to a high risk of cardiovascular events based on 8 risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, HDL-cholesterolemia and antihypertensive treatment);
•6. Following drug therapy for cholesterol even at low doses;
•7. Taking supplements to control cholesterol, blood sugar and metabolic syndrome, in the two weeks prior to recruitment;
•8. Women who are pregnant, suspect pregnancy or planning pregnancy;
•9. Women who are breastfeeding;
•10. Blood donors in the three months prior to recruitment;
•11. Non-self-sufficient individuals;
•12. Who do not show a propensity to collaborate;
•13. Who have difficulty getting to the reference facility within the scheduled time;
•14. Who are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment.

发起方

Istituto Nazionale Biostrutture e Biosistemi