Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Seoul National University

Status: Unknown

Conditions: Insulin Resistance; Decreased Pulmonary Function

Treatments: Other: PVC containing packing materials; Other: non- PVC containing packing materials

Study type: Interventional

Funder types: Other

Identifiers

NCT02284477

2014-2075

Details and patient eligibility

About

• 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

non- PVC containing packing materials

Experimental group

Description:

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.

Treatment:

Other: non- PVC containing packing materials

PVC containing packing materials

Experimental group

Description:

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.

Treatment:

Other: PVC containing packing materials

Only lunch and dinner

No Intervention group

Description:

Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.