Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

January 27, 2015 updated by: Seoul National University Hospital
  • Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent.
  • Phthalate is mainly used as PVC plasticizer and easily found in commonly used products such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc. Especially, PVC blood bag used for blood transfusion have been reported to have high level of phthalate concentration.
  • Previous studies reported that urinary concentration of phthalate metabolites and HOMA (Homeostatic model assessment, indicator of insulin resistance) has positive association.
  • Previous studies also reported negative associations between urinary phthalate concentration and pulmonary function.
  • Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate containing package material is expected to be one of the major contributor for phthalate exposure.
  • In this present trial, the investigators are to examine whether increased phthalate exposure by consuming beverage stored in PVC containing packing materials actually effect insulin resistance, pulmonary function and epigenetic feature.
  • For this aim, the investigators will conduct a cross-over trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

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

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who understand aim of this study and who provided informed consent

Exclusion Criteria:

  • Who did not provided informed consent
  • Person who are undergoing or planning to take a treatment due to liver, nervous system, respiratory system, hematologic, oncologic, psychiatric, cardiovascular(angina pectoris, myocardial infarction, stroke etc), endocrinal(Diabetes mellitus, thyroid disease) disorders.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: non- PVC containing packing materials
Participants will be provided food for lunch and dinner with 360mL apple juice which was stored in glass bottle for 24 hours in 4 ℃. After 1 week, participant will cross over to other intervention.
Other: non- PVC containing packing materials
Beverage which was stored in glass bottle for 24 hours in 4 ℃.
Other Names:
  • Beverage stored in glass bottle
Experimental: PVC containing packing materials
Participants will be provided food for lunch and dinner with 360mL apple juice which was stored in PVC blood bag for 24 hours in 4 ℃. After 1 week, participant will cross over to other intervention.
Other: PVC containing packing materials
Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.
Other Names:
  • Beverage stored in blood bag
No Intervention: Only lunch and dinner
Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of DNA methylation assessed by Percent DNA methylation
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FVC
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1/FVC
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEF25-75
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and beverage
Increased exposure to Phthalate assessed by urinary concentration of metabolites
Time Frame: average 14 hours after consumption of assigned food and beverage
average 14 hours after consumption of assigned food and 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, College of Medicine, Seoul National Unveirsity

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

January 1, 2015

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-2075

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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