Effect of Puerarin on Heart Health in Men

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Disease Risk Factors

Treatments: Drug: Placebo; Drug: Puerarin

Study type: Interventional

Funder types: Other

Identifiers

NCT03676296

NCD001.0

Details and patient eligibility

About

This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.

Full description

Objectives: To assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.

Study design: A randomized, double-blind, placebo-controlled, 2-way crossover trial of 12-week puerarin supplementation.

Study subjects: 234 Hong Kong Chinese men aged 18-50 years without a history of cardiovascular disease.

Intervention: After assessing eligibility, all participants will be randomized to take a puerarin supplement in granules (90.2 mg daily) or a placebo, followed by a 4-week wash-out period, after which participants will be crossed over to the other intervention.

Primary outcomes: Lipid profile (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, triglycerides).

Secondary outcomes: Cardiovascular disease risk factors, such as blood pressure and fasting glucose, as well as some potential mediating pathways, such as testosterone.

Methods: An intention to treat analysis will be used, assuming no changes in baseline value for missing follow up values. Differences in outcomes between supplementation and placebo within participants will be compared using a paired t-test, after checking for the possibility of a carryover effect.

Expected results: The short-term effect of puerarin on cardiovascular disease risk factors in men will be obtained so as to confirm or refute previous trials usually with small sample sizes that suggest puerarin may improve lipid profile and reduce testosterone. The findings will also add evidence about the effects of puerarin on other potentially relevant risk factors, such as blood pressure, fasting glucose and testosterone, as well as some related biomarkers.

Enrollment: 217 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men
• Aged 18 to 50 years
• Chinese ethnicity
• Willing to make return visits
• Not currently taking any traditional Chinese medicine (including puerarin) supplementation
• Not currently receiving hormone replacement therapy, such as testosterone replacement therapy, in the past 12 months
• Free of any congenital diseases
• Free of any infectious diseases e.g. seasonal influenza
• With no history of any chronic diseases including coronary heart disease (ischemic heart disease), myocardial infarction (heart attack), stroke, diabetes and cancer
• Have a 10-year risk of ischemic heart disease of less than 10%

Exclusion criteria

• Women
• Men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

217 participants in 2 patient groups, including a placebo group

Puerarin

Experimental group

Description:

Puerarin (90.2 mg daily) in granules

Treatment:

Drug: Placebo

Drug: Puerarin

Placebo

Placebo Comparator group

Description:

Placebo in granules

Treatment:

Drug: Placebo

Drug: Puerarin