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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 35
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Taoyuan branch of Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Yueh Hsiang Huang, PhD
igighuang@gmail.com
886-975360240
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Group 1
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov