Red Yeast Rice for Primary Prevention of Hypercholesterolemia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: LipoCol Forte Capsule 600mg bid

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Yueh Hsiang Huang, PhD; Phone Number: 886-975360240; Email: igighuang@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Taoyuan branch of Chang Gung Memorial Hospital
    • Contact: Yueh Hsiang Huang, PhD; Phone Number: 886-975360240; Email: igighuang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: LipoCol Forte Capsule 600mg bid; LipoCol Forte Capsule 600mg bid for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 202301060A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No