Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change

March 23, 2014 updated by: Yun-Chul Hong, Seoul National University Hospital
  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-799
        • Department of Preventive Medicine, College of Medicine, Seoul National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Reside in Seoul
  • Who provided Informed consent

Exclusion Criteria:

  • Who has cancer
  • Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
  • Who does not provieded informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glass
consume beverage in glass first and cross over to other interventions
Other: Can 1
drink the beverage in a can and a glass bottle
Other: Can 2
Consume two canned beverage
Other: Glass
consume two glass bottled beverage
Experimental: Can 1
consume one canned beverage and a glass bottled beverage first and cross over to other interventions
Other: Can 1
drink the beverage in a can and a glass bottle
Other: Can 2
Consume two canned beverage
Other: Glass
consume two glass bottled beverage
Experimental: Can 2
Consume two canned beverage first and cross over to other interventions
Other: Can 1
drink the beverage in a can and a glass bottle
Other: Can 2
Consume two canned beverage
Other: Glass
consume two glass bottled beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: 2 hours after consuming beverage
2 hours after consuming beverage

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent DNA methylation
Time Frame: 2 hours after consuming the beverage
2 hours after consuming the beverage
Heart Rate Variablility
Time Frame: 2 hours after consuming the beverage
2 hours after consuming the beverage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Yun-Chul Hong, MD, PhD, Department of Preventive Medicine, College of Medicine, Seoul National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 2, 2014

First Submitted That Met QC Criteria

March 23, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 23, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPA-CAN-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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