Effect of Puerarin on Heart Health in Men

Phase 2

Completed

• Conditions: Cardiovascular Disease Risk Factors
• Interventions: Drug: Puerarin; Drug: Placebo

• Registration Number: NCT03676296
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Status Verified: 2021-04
• Primary Completion: 2021-04-17
• Study Completion: 2021-04-17
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 217

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%

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Puerarin	Placebo	Puerarin (90.2 mg daily) in granules
Placebo	Puerarin	Placebo in granules
Placebo	Placebo	Placebo in granules
Puerarin	Puerarin	Puerarin (90.2 mg daily) in granules

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China