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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90678255

Enrollment

Registered

2023-11-29

Start date

2023-09-21

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild hypercholesterolemia Nutritional, Metabolic, Endocrine

Interventions

The subjects recruited in the present clinical study will consume a food supplement based on red yeast rice (monacolin K), gamma-oryzanol from rice bran, and gamma-aminobutyric acid, or a placebo, for

baseline = t0

after 30 days of treatment = t1

after 90 days of treatment = t2) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. The clinical trial design is reported below: During the screening vi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Aged 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.

Design outcomes

Primary

Measure	Time frame
Plasmatic LDL determination measured using blood sample analysis at the screening visit (tr), baseline (t0), 90 days of treatment (t2)	—

Secondary

Measure	Time frame
1. Determination of blood levels of TC, HDL cholesterol, TG measured using blood sample analysis at the screening visit (tr) –TC and HDL only, baseline (t0), 90 days of treatment (t2). 2. Determination of blood levels of HbA1c, and fasting blood glucose measured using blood sample analysis at baseline (t0), 90 days of treatment (t2). 3. BMI (kg/m²) and waist circumference (cm) measured using anthropometric measures at baseline (t0), 90 days of treatment (t2). 4. Inflammatory levels, leucocyte, ESR, CRP measured using blood sample analysis at baseline (t0), 90 days of treatment (t2). 5. Liver and kidney toxicity, blood concentration of the following biomarkers GOT, GPT, and creatinine measured using blood sample analysis at baseline (t0), 30 days of treatment (t1), 90 days of treatment (t2).	—

Measure

Time frame

1. Determination of blood levels of TC, HDL cholesterol, TG measured using blood sample analysis at the screening visit (tr) –TC and HDL only, baseline (t0), 90 days of treatment (t2). 2. Determination of blood levels of HbA1c, and fasting blood glucose measured using blood sample analysis at baseline (t0), 90 days of treatment (t2). 3. BMI (kg/m²) and waist circumference (cm) measured using anthropometric measures at baseline (t0), 90 days of treatment (t2). 4. Inflammatory levels, leucocyte, ESR, CRP measured using blood sample analysis at baseline (t0), 90 days of treatment (t2). 5. Liver and kidney toxicity, blood concentration of the following biomarkers GOT, GPT, and creatinine measured using blood sample analysis at baseline (t0), 30 days of treatment (t1), 90 days of treatment (t2).

—

Countries

Italy

Contacts

Public ContactAlessandra Baldi

alessandra.baldi.alimenti@gmail.com+39 06 35340153

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026