The beneficial effect on cardiovascular function of a food supplement based on red yeast rice (monacolin K), gamma-oryzanol from rice bran, and gamma-aminobutyric acid.
- Conditions
- Mild hypercholesterolemiaNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN90678255
- Lead Sponsor
- Istituto Nazionale Biostrutture e Biosistemi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 88
1. Subjects aged 18-70 years of both sexes;
2. Subjects able to understand and sign the informed consent;
3. 200 mg/dL < Total Cholesterol < 239 mg/dL;
4. LDL cholesterol < 159 mg/dL.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method