Clinical trial NCT06301906: Red Yeast Rice for Primary Prevention of Hypercholesterolemia
Official title: Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 50
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition.

Brief summary: This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.


Eligibility criteria: Inclusion Criteria:

* Aged 35\~55 years old, LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl, expected to receive LipoCol Forte Capsule 600mg bid

Exclusion Criteria:

1. Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
2. Female;
3. Have experienced rhabdomyolysis or abnormal liver function ALT \>72 U/L due to taking red yeast rice;
4. Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
5. Liver insufficiency ALT \>72 U/L or renal insufficiency eGFR \< 30 mL/min/1.73 m2;
6. Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
7. Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
8. Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
9. Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
10. Drug abuse or poor compliance;
11. Use of traditional Chinese medicine in the past month

Primary outcomes:
measure: Low Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: before treatment, and 3, 6, 9, 12 months after treatments
Secondary outcomes:
measure: 10-Year ASCVD Risk
timeFrame: before treatment, and 3, 6, 9, 12 months after treatments
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan branch of Chang Gung Memorial Hospital
Study officials:
References: