Effect of Puerarin on Heart Health in Men

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

Detailed Description
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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.

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

Conditions
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Cardiovascular Disease Risk Factors

Intervention / Treatment
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* Drug: Puerarin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Puerarin, Lipids, Testosterone