Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Not Applicable

• Conditions: Insulin Resistance; Decreased Pulmonary Function
• Interventions: Other: non- PVC containing packing materials; Other: PVC containing packing materials

• Registration Number: NCT02284477
• Lead Sponsor: Seoul National University Hospital

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-06
• Study Start: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
non- PVC containing packing materials	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.
PVC containing packing materials	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.

Primary Outcome Measures

Name	Time	Method
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)	average 14 hours after consumption of assigned food and beverage

Secondary Outcome Measures

Name	Time	Method
Decrease of lung function assessed by FEF25-75	average 14 hours after consumption of assigned food and beverage
Increased exposure to Phthalate assessed by urinary concentration of metabolites	average 14 hours after consumption of assigned food and beverage
Change of DNA methylation assessed by Percent DNA methylation	average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1	average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FVC	average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1/FVC	average 14 hours after consumption of assigned food and beverage

Trial Locations

Locations (1)

Department of Preventive Medicine, College of Medicine, Seoul National University; 🇰🇷 Seoul, Korea, Republic of