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

Primary Purpose

Hypertension

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Can 1

Can 2

Glass

About this trial

This is an interventional basic science trial for Hypertension

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Preventive Medicine, College of Medicine, Seoul National University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Glass

Can 1

Can 2

Arm Description

consume beverage in glass first and cross over to other interventions

consume one canned beverage and a glass bottled beverage first and cross over to other interventions

Consume two canned beverage first and cross over to other interventions

Outcomes

Primary Outcome Measures

Blood Pressure

Secondary Outcome Measures

Percent DNA methylation

Heart Rate Variablility

Full Information

NCT ID

NCT02096991

First Posted

February 2, 2014

Last Updated

March 23, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02096991

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glass

Arm Type

Active Comparator

Arm Description

consume beverage in glass first and cross over to other interventions

Arm Title

Can 1

Arm Type

Experimental

Arm Description

consume one canned beverage and a glass bottled beverage first and cross over to other interventions

Arm Title

Can 2

Arm Type

Experimental

Arm Description

Consume two canned beverage first and cross over to other interventions

Intervention Type

Other

Intervention Name(s)

Can 1

Intervention Description

drink the beverage in a can and a glass bottle

Intervention Type

Other

Intervention Name(s)

Can 2

Intervention Description

Consume two canned beverage

Intervention Type

Other

Intervention Name(s)

Glass

Intervention Description

consume two glass bottled beverage

Primary Outcome Measure Information:

Title

Blood Pressure

Time Frame

2 hours after consuming beverage

Secondary Outcome Measure Information:

Title

Percent DNA methylation

Time Frame

2 hours after consuming the beverage

Title

Heart Rate Variablility

Time Frame

2 hours after consuming the beverage

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun-Chul Hong, MD, PhD

Organizational Affiliation

Department of Preventive Medicine, College of Medicine, Seoul National University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Preventive Medicine, College of Medicine, Seoul National University

City

Seoul

ZIP/Postal Code

110-799

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25489056

Citation

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.

Results Reference

derived

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

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