Red Yeast Rice for Primary Prevention of Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301906
• Other study ID #: 202301060A3
• Status: Recruiting
• Start date: February 26, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Yueh Hsiang Huang, PhD
• Phone: 886-975360240
• Email: igighuang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• LipoCol Forte Capsule 600mg bid
LipoCol Forte Capsule 600mg bid for 12 months

Locations

Country	Name	City	State
Taiwan	Taoyuan branch of Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Density Lipoprotein-Cholesterol (LDL-C)	This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.	before treatment, and 3, 6, 9, 12 months after treatments
Secondary	10-Year ASCVD Risk	use ASCVD risk estimator to calculate the 10-Year ASCVD Risk after LipoCol Forte capsules treatment	before treatment, and 3, 6, 9, 12 months after treatments