Clinical trial NCT06782646: Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine
Official title: Assessing the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine Using Randomized, Placebo-controlled, Double-masked Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia
berberine
lipoprotein
lipid
sex-hormones
apoA1
apoB
Lp(a)
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if berberine works to affect lipids and lipoproteins in Chinese females aged 20 to 65 years with hyperlipidaemia. The goal also includes to examine the sex-specific effect of berberine on lipids and lipoproteins. Our previous HMRF-funded randomized trial in men and prior evidence suggests berberine affects sex hormones. Given the different sex hormone profiles in men and women, the main question it aims to answer is:

• Does berberine have sex-specific lipid-modifying effects? Researchers will compare berberine to a placebo (a look-alike substance that contains no drug) to see if berberine works to affect lipids and lipoproteins.

Participants will:

* Take a baseline questionnaire
* Take berberine or a placebo every day for 12 weeks
* Take follow-up visits after 8 weeks and 12 weeks for blood sample collections and tests

Detailed description: 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 completed RCT of berberine in men; 3) assess whether the effects of berberine on lipids, lipoproteins and sex hormones differ in men and women.

This is a randomized, parallel, double-blinded, placebo-controlled trial of berberine in 100 Chinese women with hyperlipidemia in Hong Kong.

Participants will be randomized to two arms in which half of the participants will receive berberine (500 mg orally twice a day) and the other half will receive placebos (500 mg orally twice a day) for 12 weeks. Blood samples will be taken at baseline, 8-week and 12-week intervention.

The investigators will use an intention-to-treat analysis. Changes in lipids and lipoproteins after 8- and 12-week treatment will be assessed using analysis of variance and generalized estimating equation (GEE) model accounting for measurements at both time points.

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.

Primary outcomes:
measure: Total cholesterol in mmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: LDL-cholesterol in mmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Triglycerides in mmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Apolipoprotein B in mg/dL
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Lipoprotein (a) in mg/dL
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
Secondary outcomes:
measure: HDL-cholesterol in mmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Non-HDL-cholesterol in mmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Apolipoprotein A1 in mg/dL
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Estradiol (E2) in pg/mL
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Sex hormone binding globulin (SHBG) in nmol/L
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
measure: Testosterone in ng/dL
timeFrame: 4 months for biomarker assessment, 6 months for data analysis
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Public Health, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Jie Zhao, Dr
role: PRINCIPAL_INVESTIGATOR
References: