Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine
Launched by THE UNIVERSITY OF HONG KONG · Jan 17, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The overall aim of the project is to assess the sex-specific effects of berberine on lipids, apoA1, apoB, and Lp(a). Specifically, the objectives of the project are to 1) assess the effect of berberine on lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL cholesterol, and TG), lipoproteins (apoA1, apoB, and Lp(a)) and sex hormones by conducting a randomized, parallel, double-masked, placebo-controlled trial of berberine RCT in women; 2) assess the effect of berberine on apoA1, apoB, Lp(a) and sex hormone binding globulin (SHBG) in men using stored samples from our complete...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- * Women, who are:
- • 1. aged 20 to 65 years.
- • 2. of Chinese ethnicity.
- • 3. with hyperlipidemia, defined as TG greater than 150 mg/dl (1.70 mmol/L), total cholesterol greater than 200 mg/dl (5.16 mmol/L), and/or LDL-cholesterol greater than 100 mg/dl (2.58 mmol/L).
- • 4. willing to make return visits.
- • 5. not currently receiving hormone replacement therapy or medications/pills containing hormones (such as hormonal contraception or hormone replacement therapy) in the past 12 months.
- • 6. not currently taking berberine or nutraceuticals that contain berberine.
- • 7. free of any congenital diseases, including familial hypercholesterolemia.
- • 8. free of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. G6PD will be tested using G6PD rapid diagnostic tests.
- • 9. free of hemolytic anemia.
- • 10. free of any infectious diseases, e.g., seasonal influenza.
- • 11. without liver/renal diseases.
- • 12. not pregnant or planning to get pregnant in the next three months. Pregnancy will be ruled out using HCG ULTRA pregnancy tests.
- • 13. not currently breastfeeding.
- Exclusion Criteria:
- • All men, and women who did not meet the aforementioned inclusion criteria and/or were unable or unwilling to provide consent.
About The University Of Hong Kong
The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hong Kong, , Hong Kong
Patients applied
Trial Officials
Jie Zhao, Dr
Principal Investigator
The University of Hong Kong
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported