A Mechanistic Randomized Controlled Trial on the Cardiovascular Effect of Berberine

• Status: Completed
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

Berberine is extracted from Coptis (Huanglian) and Phellodendron Chinese (Huangbai), to make into berberine tablets.1 Recent studies have shown that berberine has beneficial effects on cardiovascular disease (CVD) risk factors,1,2 such as lowering the risk of hyperlipidemia, diabetes, and hypertension.1 In a comprehensive systematic review and meta-analysis of 27 randomized controlled trials (RCTs), berberine effectively reduced low density lipoprotein cholesterol (LDL-c) (-0.65 mmol/L, 95% confidence interval (CI) -0.75 to -0.56), triglycerides (TG) (-0.39 mmol/L, 95% CI -0.59 to -0.19), total cholesterol (TC) (-0.66 mmol/L, 95% CI -1.02 to -0.31) and increased high density lipoprotein cholesterol (HDL-c) (0.07mmol/L, 95% CI 0.04 to 0.1).1 Notably, no serious adverse event has been reported in these trials,1 suggesting a good tolerability of berberine. The mechanism by which berberine exerts a protective role in atherosclerosis is unclear. Protoberberines have been identified as a new inhibitor of AKR1C3, an enzyme responsible for the regulation of steroid hormone action.3 The investigators propose to examine the effects of berberine on a set of well-established CVD risk factors including lipids, systolic and diastolic blood pressure, coagulation factors, adiposity, fasting glucose, insulin, and liver function, as well as to examine potential mediation via testosterone and/or sex hormone binding globulin using a mechanistic, randomized, double-blind, placebo-controlled trial in Chinese men with hyperlipidemia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: Food and Health Bureau, Hong Kong

Criteria

Inclusion Criteria:

• Men, 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), TC greater than 200 mg/dl (5.16 mmol/L), and/or LDL-c greater than 100 mg/dl (2.58 mmol/L)

4. willing to make return visits

5. not currently receiving hormone replacement therapy, such as testosterone replacement therapy, in the past 12 months

6. not currently taking berberine or traditional Chinese medicine that contains berberine, in the past 1 month

7. free of any congenital diseases, including familial hypercholesterolemia

8. free of any infectious diseases, e.g. seasonal influenza

9. free of anemia and glucose-6-phosphate dehydrogenase deficiency

10. with no history of any chronic diseases including ischemic heart disease, myocardial infarction (heart attack), stroke, diabetes, cancer, liver/renal dysfunction, and gastrointestinal disorders.

Exclusion Criteria:

• All women, and men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent