NCT06301906

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	LipoCol Forte Capsule 600mg twice a day	LipoCol Forte Capsule 600mg twice a day for 12 months

Timeline

• Start date: 2024-02-26
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-08
• Last updated: 2026-03-20

Locations

1 site across 1 country: Taiwan