Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
NCT ID: NCT02284477
Last Updated: 2015-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-01-31
2015-04-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
non- PVC containing packing materials
Beverage which was stored in glass bottle for 24 hours in 4 ℃.
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.
PVC containing packing materials
Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.
Only lunch and dinner
Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.
No interventions assigned to this group
Interventions
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non- PVC containing packing materials
Beverage which was stored in glass bottle for 24 hours in 4 ℃.
PVC containing packing materials
Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
60 Years
85 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yun-Chul Hong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
College of Medicine, Seoul National Unveirsity
Locations
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Department of Preventive Medicine, College of Medicine, Seoul National University
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Stahlhut RW, van Wijngaarden E, Dye TD, Cook S, Swan SH. Concentrations of urinary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males. Environ Health Perspect. 2007 Jun;115(6):876-82. doi: 10.1289/ehp.9882. Epub 2007 Mar 14.
Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, Ackerman JM, Rizzo J, Nudelman JL, Brody JG. Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention. Environ Health Perspect. 2011 Jul;119(7):914-20. doi: 10.1289/ehp.1003170. Epub 2011 Mar 30.
Singh S, Li SS. Epigenetic effects of environmental chemicals bisphenol A and phthalates. Int J Mol Sci. 2012;13(8):10143-10153. doi: 10.3390/ijms130810143. Epub 2012 Aug 15.
Manikkam M, Tracey R, Guerrero-Bosagna C, Skinner MK. Plastics derived endocrine disruptors (BPA, DEHP and DBP) induce epigenetic transgenerational inheritance of obesity, reproductive disease and sperm epimutations. PLoS One. 2013;8(1):e55387. doi: 10.1371/journal.pone.0055387. Epub 2013 Jan 24.
Kim JH, Hong YC. HSP70-hom gene polymorphisms modify the association of diethylhexyl phthalates with insulin resistance. Environ Mol Mutagen. 2014 Dec;55(9):727-34. doi: 10.1002/em.21884. Epub 2014 Jul 7.
Kim JH, Park HY, Bae S, Lim YH, Hong YC. Diethylhexyl phthalates is associated with insulin resistance via oxidative stress in the elderly: a panel study. PLoS One. 2013 Aug 19;8(8):e71392. doi: 10.1371/journal.pone.0071392. eCollection 2013.
Hoppin JA, Tolbert PE, Flagg EW, Blair A, Zahm SH. Use of a life events calendar approach to elicit occupational history from farmers. Am J Ind Med. 1998 Nov;34(5):470-6. doi: 10.1002/(sici)1097-0274(199811)34:53.0.co;2-u.
Zahm SH, Colt JS, Engel LS, Keifer MC, Alvarado AJ, Burau K, Butterfield P, Caldera S, Cooper SP, Garcia D, Hanis C, Hendrikson E, Heyer N, Hunt LM, Krauska M, MacNaughton N, McDonnell CJ, Mills PK, Mull LD, Nordstrom DL, Outterson B, Slesinger DP, Smith MA, Stallones L, Stephens C, Sweeney A, Sweitzer K, Vernon SW, Blair A. Development of a life events/icon calendar questionnaire to ascertain occupational histories and other characteristics of migrant farmworkers. Am J Ind Med. 2001 Nov;40(5):490-501. doi: 10.1002/ajim.1117.
van der Mei IA, Blizzard L, Ponsonby AL, Dwyer T. Validity and reliability of adult recall of past sun exposure in a case-control study of multiple sclerosis. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1538-44. doi: 10.1158/1055-9965.EPI-05-0969.
Other Identifiers
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2014-2075
Identifier Type: -
Identifier Source: org_study_id
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