HypertensionNCT02096991
Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
A study testing Can 1, Can 2 and Glass in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen. Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases. Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Can 1, Can 2 and Glass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 2014
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reside in Seoul
- Who provided Informed consent
Who cannot join
- Who has cancer
- Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
- Who does not provieded informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Preventive Medicine, College of Medicine, Seoul National University
Seoul, 110-799
About this study
- Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen.
- Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases.
- Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source.
- The investigators hypothesis is that increased BPA exposure from canned beverage would disrupt normal physiology in a short term.
- In the present trial the investigators are to investigate whether increased BPA exposure by consuming canned beverage actually affect cardiovascular indices and epigenetic feature.
- For this aim, the investigators will conduct a cross-over trial.
- Conditions
- Hypertension
- Being tested
- Can 1, Can 2, Glass
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Can 1Other
drink the beverage in a can and a glass bottle
Can 2Other
Consume two canned beverage
GlassOther
consume two glass bottled beverage
| Study group | Role | What they receive |
|---|---|---|
| Glass | Active comparator | consume beverage in glass first and cross over to other interventions Receives: Other: Can 1; Other: Can 2; Other: Glass |
| Can 1 | Experimental | consume one canned beverage and a glass bottled beverage first and cross over to other interventions Receives: Other: Can 1; Other: Can 2; Other: Glass |
| Can 2 | Experimental | Consume two canned beverage first and cross over to other interventions Receives: Other: Can 1; Other: Can 2; Other: Glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: 2 hours after consuming beverage
Secondary outcomes (2)
Percent DNA methylation
Measured: 2 hours after consuming the beverage
Heart Rate Variablility
Measured: 2 hours after consuming the beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Chul Hong, Seoul National University Hospital
- Investigators
- Yun-Chul Hong, MD, PhD, Principal investigator, Department of Preventive Medicine, College of Medicine, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096991
- Sponsor's protocol ID
- BPA-CAN-1
- Status last verified
- Mar 2014
- First submitted
- 2 Feb 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bae S, Hong YC. Exposure to bisphenol A from drinking canned beverages increases blood pressure: randomized crossover trial. Hypertension. 2015 Feb;65(2):313-9. doi: 10.1161/HYPERTENSIONAHA.114.04261. Epub 2014 Dec 8.
PubMed 25489056
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
- ClinicalTrials.gov ID
- NCT02096991
- Acronym / sponsor ID
- BPA-CAN-1
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
- Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen.
- Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases.
- Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source.
- The investigators hypothesis is that increased BPA exposure from canned beverage would disrupt normal physiology in a short term.
- In the present trial the investigators are to investigate whether increased BPA exposure by consuming canned beverage actually affect cardiovascular indices and epigenetic feature.
- For this aim, the investigators will conduct a cross-over trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass | Active comparator | Other: Can 1, Other: Can 2, Other: Glassconsume beverage in glass first and cross over to other interventions |
| Can 1 | Experimental | Other: Can 1, Other: Can 2, Other: Glassconsume one canned beverage and a glass bottled beverage first and cross over to other interventions |
| Can 2 | Experimental | Other: Can 1, Other: Can 2, Other: GlassConsume two canned beverage first and cross over to other interventions |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Reside in Seoul
- Who provided Informed consent
Key exclusion criteria (3 listed)
- Who has cancer
- Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
- Who does not provieded informed 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 |
|---|---|---|
| Can 1drink the beverage in a can and a glass bottle | Other | Can 1, Can 2, Glass |
| Can 2Consume two canned beverage | Other | Can 1, Can 2, Glass |
| Glassconsume two glass bottled beverage | Other | Can 1, Can 2, Glass |
Primary outcome
Blood Pressure
Time frame: 2 hours after consuming beverage
2 secondary outcomes
Percent DNA methylation
Time frame: 2 hours after consuming the beverage
Heart Rate Variablility
Time frame: 2 hours after consuming the beverage
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 26 Mar 2014.
- Derived from this study: PubMed 25489056Bae S, Hong YC. Exposure to bisphenol A from drinking canned beverages increases blood pressure: randomized crossover trial. Hypertension. 2015 Feb;65(2):313-9. doi: 10.1161/HYPERTENSIONAHA.114.04261. Epub 2014 Dec 8.
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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.
Yun-Chul Hong, MD, PhD principal investigator
Department of Preventive Medicine, College of Medicine, Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Can 1, Can 2 and Glass in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 3 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 26 Mar 2014. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Blood Pressure (time frame: 2 hours after consuming beverage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096991, which also lists 1 linked publication.
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 26 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.