Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
1 other identifier
interventional
60
1 country
1
Brief 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Feb 2014
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedMarch 26, 2014
March 1, 2014
28 days
February 2, 2014
March 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Pressure
2 hours after consuming beverage
Secondary Outcomes (2)
Percent DNA methylation
2 hours after consuming the beverage
Heart Rate Variablility
2 hours after consuming the beverage
Study Arms (3)
Glass
ACTIVE COMPARATORconsume beverage in glass first and cross over to other interventions
Can 1
EXPERIMENTALconsume one canned beverage and a glass bottled beverage first and cross over to other interventions
Can 2
EXPERIMENTALConsume two canned beverage first and cross over to other interventions
Interventions
Eligibility Criteria
You may qualify if:
- Reside in Seoul
- Who provided Informed consent
You may not qualify if:
- Who has cancer
- Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
- Who does not provieded informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Preventive Medicine, College of Medicine, Seoul National University
Seoul, 110-799, South Korea
Related Publications (1)
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.
PMID: 25489056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun-Chul Hong, MD, PhD
Department of Preventive Medicine, College of Medicine, Seoul National University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2014
First Posted
March 26, 2014
Study Start
February 1, 2014
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
March 26, 2014
Record last verified: 2014-03