Clinical trial NCT03676296: Effect of Puerarin on Heart Health in Men
Official title: Effect of Puerarin Supplementation on Cardiovascular Disease Risk Factors in Men: a Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease Risk Factors
Keywords: Puerarin
Lipids
Testosterone
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2018-09-18
Enrollment: 217
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total cholesterol
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
measure: Change in low density lipoprotein (LDL) cholesterol
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
measure: Change in high density lipoprotein (HDL) cholesterol
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
measure: Change in triglycerides
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
measure: Change in fasting glucose
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
measure: Change in testosterone
timeFrame: Baseline, 12 weeks, 16 weeks and 28 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Gabriel M Leung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: