Cardiovascular Disease Risk FactorsPhase 2NCT03676296
Effect of Puerarin on Heart Health in Men
A Phase 2 study testing Puerarin in people with Cardiovascular Disease Risk Factors, run by The University of Hong Kong at 1 site in China.
Trial summary
This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Factors
- What is being tested?
- Puerarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2018to 17 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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%
Who cannot join
- Women
- Men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Puerarin Supplementation on Cardiovascular Disease Risk Factors in Men: a Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial
This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.
Read the 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.
- Conditions
- Cardiovascular Disease Risk Factors
- Being tested
- Puerarin, Placebo
- Keywords
- Puerarin, Lipids, Testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuerarinDrug
Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks
PlaceboDrug
Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Puerarin | Experimental | Puerarin (90.2 mg daily) in granules Receives: Drug: Puerarin; Drug: Placebo |
| Placebo | Placebo comparator | Placebo in granules Receives: Drug: Puerarin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol
Mean difference in total cholesterol (mmol/L)
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in low density lipoprotein (LDL) cholesterol
Mean difference in LDL cholesterol (mmol/L)
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in high density lipoprotein (HDL) cholesterol
Mean difference in HDL cholesterol (mmol/L)
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in triglycerides
Mean difference in triglycerides (mmol/L)
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Secondary outcomes (3)
Change in blood pressure
Mean difference in systolic and diastolic blood pressure (mmHg)
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in fasting glucose
Mean difference in fasting glucose (mmol/L), with log transformation if appropriate
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in testosterone
Mean difference in testosterone (nmol/L), with log transformation if appropriate
Measured: Baseline, 12 weeks, 16 weeks and 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start5 Sep 2018
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease Risk FactorsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Professor Gabriel Matthew Leung, The University of Hong Kong
- Investigators
- Gabriel M Leung, M.D., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676296
- Sponsor's protocol ID
- NCD001.0
- Status last verified
- Apr 2021
- First submitted
- 11 Sep 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Puerarin Supplementation on Cardiovascular Disease Risk Factors in Men: a Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial
- ClinicalTrials.gov ID
- NCT03676296
- Acronym / sponsor ID
- NCD001.0
- Conditions
- Cardiovascular Disease Risk Factors
- Keywords
- Puerarin, Lipids, Testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puerarin | Experimental | Drug: Puerarin, Drug: PlaceboPuerarin (90.2 mg daily) in granules |
| Placebo | Placebo comparator | Drug: Puerarin, Drug: PlaceboPlacebo in granules |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Men
- Aged 18 to 50 years
- Chinese ethnicity
- Willing to make return visits
- Not currently taking any traditional Chinese medicine (including puerarin) supplementation
Key exclusion criteria (2 listed)
- Women
- Men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuerarinPuerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks | Drug | Placebo, Puerarin |
| PlaceboPlacebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks | Drug | Placebo, Puerarin |
Primary outcome
Change in total cholesterol
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Mean difference in total cholesterol (mmol/L)
Change in low density lipoprotein (LDL) cholesterol
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Mean difference in LDL cholesterol (mmol/L)
Change in high density lipoprotein (HDL) cholesterol
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Mean difference in HDL cholesterol (mmol/L)
Change in triglycerides
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Mean difference in triglycerides (mmol/L)
3 secondary outcomes
Change in blood pressure
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in fasting glucose
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Change in testosterone
Time frame: Baseline, 12 weeks, 16 weeks and 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel M Leung, M.D. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Puerarin in people with Cardiovascular Disease Risk Factors, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total cholesterol (time frame: Baseline, 12 weeks, 16 weeks and 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.