Effect of Puerarin on Heart Health in Men

Cardiovascular Disease Risk Factors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676296
• Other study ID #: NCD001.0
• Status: Completed
• Phase: Phase 2
• Start date: September 5, 2018
• Est. completion date: April 17, 2021

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 17, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Factors
• Cardiovascular Diseases

Intervention

Drug:
• Puerarin
Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks
• Placebo
Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Health and Medical Research Fund

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total cholesterol	Mean difference in total cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Primary	Change in low density lipoprotein (LDL) cholesterol	Mean difference in LDL cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Primary	Change in high density lipoprotein (HDL) cholesterol	Mean difference in HDL cholesterol (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Primary	Change in triglycerides	Mean difference in triglycerides (mmol/L)	Baseline, 12 weeks, 16 weeks and 28 weeks
Secondary	Change in blood pressure	Mean difference in systolic and diastolic blood pressure (mmHg)	Baseline, 12 weeks, 16 weeks and 28 weeks
Secondary	Change in fasting glucose	Mean difference in fasting glucose (mmol/L), with log transformation if appropriate	Baseline, 12 weeks, 16 weeks and 28 weeks
Secondary	Change in testosterone	Mean difference in testosterone (nmol/L), with log transformation if appropriate	Baseline, 12 weeks, 16 weeks and 28 weeks