Effect of Puerarin on Heart Health in Men

Effect of Puerarin Supplementation on Cardiovascular Disease Risk Factors in Men: a Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease Risk Factors
• Intervention / Treatment: Drug: Puerarin; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Puerarin; Puerarin (90.2 mg daily) in granules	Drug: Puerarin; Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks; Drug: Placebo; Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks
Placebo Comparator: Placebo; Placebo in granules	Drug: Puerarin; Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks; Drug: Placebo; Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol	Mean difference in total cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Change in low density lipoprotein (LDL) cholesterol	Mean difference in LDL cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Change in high density lipoprotein (HDL) cholesterol	Mean difference in HDL cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Change in triglycerides	Mean difference in triglycerides (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Mean difference in systolic and diastolic blood pressure (mmHg)	Baseline, 12 weeks, 16 weeks and 28 weeks
Change in fasting glucose	Mean difference in fasting glucose (mmol/L), with log transformation if appropriate	Baseline, 12 weeks, 16 weeks and 28 weeks
Change in testosterone	Mean difference in testosterone (nmol/L), with log transformation if appropriate	Baseline, 12 weeks, 16 weeks and 28 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Gabriel M Leung, M.D., The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): April 17, 2021
• Study Completion (Actual): April 17, 2021

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Lipids; Testosterone; Puerarin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vasodilator Agents; Puerarin
• Other Study ID Numbers: NCD001.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No