NCT02284477Unknown不适用
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who understand aim of this study and who provided informed consent
排除标准
- •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.
研究组 & 干预措施
non- PVC containing packing materials
Experimental
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.
干预措施: non- PVC containing packing materials (Other)
PVC containing packing materials
Experimental
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.
干预措施: PVC containing packing materials (Other)
Only lunch and dinner
No Intervention
Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.
结局指标
主要结局
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
时间窗: average 14 hours after consumption of assigned food and beverage
次要结局
- 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)
研究者
研究点 (1)
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