Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2018-09-05
2021-04-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Puerarin
Puerarin (90.2 mg daily) in granules
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
Placebo
Placebo in granules
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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Health and Medical Research Fund
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
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Professor Gabriel Matthew Leung
Professor
Principal Investigators
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Gabriel M Leung, M.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , China
Countries
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Other Identifiers
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NCD001.0
Identifier Type: -
Identifier Source: org_study_id
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