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Effect of Puerarin on Heart Health in Men

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ClinicalTrials.gov Identifier: NCT03676296
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Health and Medical Research Fund, Hong Kong
Information provided by (Responsible Party):
Professor Gabriel Matthew Leung, The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Factors Drug: Puerarin Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Puerarin Supplementation on Cardiovascular Disease Risk Factors in Men: a Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Puerarin
Puerarin (90.2 mg daily) in granules
Drug: Puerarin
Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676296


Contacts
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Contact: Catherine M Schooling, Ph.D. 852+39176732 cms1@hku.hk
Contact: Man Ki Kwok, Ph.D. 852+39176750 maggiek@hku.hk

Locations
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China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: Man Ki Kwok, Ph.D.    852+39176750    maggiek@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Health and Medical Research Fund, Hong Kong
Investigators
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Principal Investigator: Gabriel M Leung, M.D. The University of Hong Kong

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Responsible Party: Professor Gabriel Matthew Leung, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03676296     History of Changes
Other Study ID Numbers: NCD001.0
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Gabriel Matthew Leung, The University of Hong Kong:
Puerarin
Lipids
Testosterone

Additional relevant MeSH terms:
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Cardiovascular Diseases
Puerarin
Vasodilator Agents