Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Study Overview
=================
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.

Official Title
-----------------
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Conditions
-----------------
Insulin Resistance, Decreased Pulmonary Function

Intervention / Treatment
-----------------
* Other: non- PVC containing packing materials
* Other: PVC containing packing materials


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non- PVC containing packing materials<br>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<br>* Beverage which was stored in glass bottle for 24 hours in 4 ℃.<br>* Other names: Beverage stored in glass bottle;|
| Experimental: PVC containing packing materials<br>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<br>* Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.<br>* Other names: Beverage stored in blood bag;|
| No Intervention: Only lunch and dinner<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of insulin resistance assessed by HOMA (Homeostatic model assessment) |  | average 14 hours after consumption of assigned food and beverage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Pulmonary function, Phthalates