Cardiovascular Disease Risk Factors
Conditions
Keywords
Puerarin, Lipids, Testosterone
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.
Interventions
DRUGPuerarin
Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks
DRUGPlacebo
Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks
Sponsors
Health and Medical Research Fund
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in blood pressure | Baseline, 12 weeks, 16 weeks and 28 weeks | Mean difference in systolic and diastolic blood pressure (mmHg) |
Countries
China
Outcome results
None listed