Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Berberine, Placebo.
- Who it may be relevant to
- Registry conditions: Hyperlipidemia. Basic parameters: 20 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine Using Randomized, Placebo-controlled, Double-masked Trial
Overview
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.
Interventions
- Drug Berberine
Participants will take purified berberine (500 mg orally twice a day) for 12 weeks. - Drug Placebo
Participants will take placebo tablets, a look-alike substance that contains no drug, (500 mg orally twice a day) for 12 weeks.
Primary outcome measures
- Total cholesterol in mmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- LDL-cholesterol in mmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Triglycerides in mmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Apolipoprotein B in mg/dL [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Lipoprotein (a) in mg/dL [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
Secondary outcome measures (6)
- HDL-cholesterol in mmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Non-HDL-cholesterol in mmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Apolipoprotein A1 in mg/dL [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Estradiol (E2) in pg/mL [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Sex hormone binding globulin (SHBG) in nmol/L [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
- Testosterone in ng/dL [Time frame: 4 months for biomarker assessment, 6 months for data analysis]
Eligibility criteria
Inclusion criteria
- Women, who are:
- aged 20 to 65 years.
- of Chinese ethnicity.
- 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).
- willing to make return visits.
- not currently receiving hormone replacement therapy or medications/pills containing hormones (such as hormonal contraception or hormone replacement therapy) in the past 12 months.
- not currently taking berberine or nutraceuticals that contain berberine.
- free of any congenital diseases, including familial hypercholesterolemia.
- free of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. G6PD will be tested using G6PD rapid diagnostic tests.
- free of hemolytic anemia.
- free of any infectious diseases, e.g., seasonal influenza.
- without liver/renal diseases.
- not pregnant or planning to get pregnant in the next three months. Pregnancy will be ruled out using HCG ULTRA pregnancy tests.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- School of Public Health, The University of Hong Kong — Hong Kong
Identifiers
NCT: NCT06782646 · 21222191