Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine

NCT06782646 | Enrolling By Invitation Phase 2

• 1 other identifier: 21222191
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; berberine; lipoprotein; lipid; sex-hormones; apoA1; apoB; Lp(a)

Outcome Measures

Primary Outcomes (5)

• Total cholesterol in mmol/L

  Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.

  4 months for biomarker assessment, 6 months for data analysis

• LDL-cholesterol in mmol/L

  Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.

  4 months for biomarker assessment, 6 months for data analysis

• Triglycerides in mmol/L

  Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.

  4 months for biomarker assessment, 6 months for data analysis

• Apolipoprotein B in mg/dL

  Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.

  4 months for biomarker assessment, 6 months for data analysis

• Lipoprotein (a) in mg/dL

  Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.

  4 months for biomarker assessment, 6 months for data analysis

Secondary Outcomes (6)

• HDL-cholesterol in mmol/L

  4 months for biomarker assessment, 6 months for data analysis

• Non-HDL-cholesterol in mmol/L

  4 months for biomarker assessment, 6 months for data analysis

• Apolipoprotein A1 in mg/dL

  4 months for biomarker assessment, 6 months for data analysis

• Estradiol (E2) in pg/mL

  4 months for biomarker assessment, 6 months for data analysis

• Sex hormone binding globulin (SHBG) in nmol/L

  4 months for biomarker assessment, 6 months for data analysis

Study Arms (2)

Berberine Group

EXPERIMENTAL

berberine (500 mg orally twice a day)

Drug: Berberine

Placebo Group

PLACEBO COMPARATOR

placebo (500 mg orally twice a day)

Drug: Placebo

Interventions

Berberine DRUG

Participants will take purified berberine (500 mg orally twice a day) for 12 weeks.

Also known as: Berberine (500 mg orally twice a day)

Berberine Group

Placebo DRUG

Participants will take placebo tablets, a look-alike substance that contains no drug, (500 mg orally twice a day) for 12 weeks.

Also known as: Placebo (500 mg orally twice a day)

Placebo Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Berberine

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jie Zhao, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 20, 2025
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

HK (1)