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Completed

NCT Number: NCT03676296

Effect of Puerarin on Heart Health in Men

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

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Key information

Conditions

Cardiovascular Disease Risk Factors

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

The University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Puerarin

Drug

Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks

Placebo

Drug

Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks

Primary outcomes

  1. Change in total cholesterol

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in total cholesterol (mmol/L)

  2. Change in low density lipoprotein (LDL) cholesterol

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in LDL cholesterol (mmol/L)

  3. Change in high density lipoprotein (HDL) cholesterol

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in HDL cholesterol (mmol/L)

  4. Change in triglycerides

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in triglycerides (mmol/L)

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in systolic and diastolic blood pressure (mmHg)

  2. Change in fasting glucose

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in fasting glucose (mmol/L), with log transformation if appropriate

  3. Change in testosterone

    Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks

    Mean difference in testosterone (nmol/L), with log transformation if appropriate

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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