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Open Access 01-12-2022 | Study protocol

Effect of omega-3 fatty acids on TH1/TH2 polarization in individuals with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Authors: Xiaomin Wang, Shuiqin Li, Yongcan Wu, Demei Huang, Caixia Pei, Yilan Wang, Shihua Shi, Fei Wang, Zhenxing Wang

Published in: Trials | Issue 1/2022

Abstract

Background

Long-term exposure to high concentrations of PM2.5 may cause immune system dysfunction and damage to the respiratory and cardiovascular systems. PM2.5 may cause CD4 + T helper cells to polarize toward TH1 or TH2 cell types, which may be associated with the onset and progression of many human diseases. Recent studies have shown that omega-3 fatty acids can regulate human immune function and reduce physiological damage caused by air pollution; however, only limited research has examined the therapeutic effects of omega-3 fatty acids on subjects with high exposure to PM2.5 in mass transit systems such as subways.

Methods

This study was designed as a prospective, randomized, double-blinded (to participants and researchers), placebo-controlled clinical trial. The research plan is to randomly select 120 eligible adults based on the difference in PM2.5 exposure in the Chengdu subway station. They should be aged 20–65 years old and work in the subway station more than or equal to 3 times a week, each time greater than or equal to 8 h, and had worked continuously in the subway station for more than 2 years. All participants will receive omega-3 fatty acids or placebo for 8 weeks. The primary outcomes will be changes in the TH1/TH2 cell polarization index and changes in serum cytokine concentrations. Secondary outcomes will be changes in early indicators of atherosclerosis, pulmonary function, COOP/WONCA charts, and scores on the Short-Form 36 Health Survey for quality of life. Results will be analyzed to evaluate differences in clinical efficacy between the two groups. A 6-month follow-up period will be used to assess the long-term value of omega-3 fatty acids for respiratory and cardiovascular disease endpoints.

Discussion

We will explore the characteristics of the TH1/TH2 cell polarization index in a population with high exposure to PM2.5. Omega-3 fatty acids and placebo will be compared in many ways to test the effect on people exposed to PM2.5 subway stations. This study is expected to provide reliable evidence to support the promotion of omega-3 fatty acids in clinical practice to protect individuals who are highly exposed to PM2.5.

Trial registration

Chinese Clinical Trial Registry ChiCTR2000038065. Registered on September 9, 2020

Available only for authorised users

Qi Z, Chen T, Chen J, Qi X. Ambient fine particulate matter in China: its negative impacts and possible countermeasures. J Air Waste Manag Assoc. 2018;68(3):227–34. https://doi.org/10.1080/10962247.2017.1405096.CrossRefPubMed

Pinault LL, Weichenthal S, Crouse DL, Brauer M, Erickson A, Donkelaar AV, et al. Associations between fine particulate matter and mortality in the 2001 Canadian Census Health and Environment Cohort. Environ Res. 2017;159:406–15. https://doi.org/10.1016/j.envres.2017.08.037.CrossRefPubMed

Shamsipour M, Hassanvand MS, Gohari K, Yunesian M, Fotouhi A, Naddafi K, et al. National and sub-national exposure to ambient fine particulate matter (PM(2.5)) and its attributable burden of disease in Iran from 1990 to 2016. Environ Pollut. 2019;255(Pt 1):113173. https://doi.org/10.1016/j.envpol.2019.113173.CrossRefPubMed

Schulz AJ, Mentz GB, Sampson N, Ward M, Dvonch JT, de Majo R, et al. Independent and joint contributions of fine particulate matter exposure and population vulnerability to mortality in the Detroit metropolitan area. Int J Environ Res Public Health. 2018;15(6):1209. https://doi.org/10.3390/ijerph15061209.CrossRefPubMedCentral

Kim KH, Kabir E, Kabir S. A review on the human health impact of airborne particulate matter. Environ Int. 2015;74:136–43. https://doi.org/10.1016/j.envint.2014.10.005.CrossRefPubMed

Johansson C, Norman M, Gidhagen L. Spatial & temporal variations of PM10 and particle number concentrations in urban air. Environ Monit Assess. 2007;127(1-3):477–87. https://doi.org/10.1007/s10661-006-9296-4.CrossRefPubMed

Löndahl J, Pagels J, Swietlicki E, Zhou J, Ketzel M, Massling A, et al. A set-up for field studies of respiratory tract deposition of fine and ultrafine particles in humans. J Aerosol Sci. 2006;37(9):1152–63. https://doi.org/10.1016/j.jaerosci.2005.11.004.CrossRef

Löndahl J, Massling A, Pagels J, Swietlicki E, Vaclavik E, Loft S. Size-resolved respiratory-tract deposition of fine and ultrafine hydrophobic and hygroscopic aerosol particles during rest and exercise. Inhal Toxicol. 2007;19(2):109–16. https://doi.org/10.1080/08958370601051677.CrossRefPubMed

Møller P, Folkmann JK, Forchhammer L, Bräuner EV, Danielsen PH, Risom L, et al. Air pollution, oxidative damage to DNA, and carcinogenesis. Cancer Lett. 2008;266(1):84–97. https://doi.org/10.1016/j.canlet.2008.02.030.CrossRefPubMed

10.

Chen CH, Wu CD, Chiang HC, Chu D, Lee KY, Lin WY, et al. The effects of fine and coarse particulate matter on lung function among the elderly. Sci Rep. 2019;9(1):14790. https://doi.org/10.1038/s41598-019-51307-5.CrossRefPubMedPubMedCentral

11.

Cooper DM, Loxham M. Particulate matter and the airway epithelium: the special case of the underground? Eur Respir Rev. 2019;28(153):190066. https://doi.org/10.1183/16000617.0066-2019.CrossRefPubMed

12.

Martins V, Moreno T, Mendes L, Eleftheriadis K, Diapouli E, Alves CA, et al. Factors controlling air quality in different European subway systems. Environ Res. 2016;146:35–46. https://doi.org/10.1016/j.envres.2015.12.007.CrossRefPubMed

13.

Minguillón MC, Reche C, Martins V, Amato F, de Miguel E, Capdevila M, et al. Aerosol sources in subway environments. Environ Res. 2018;167:314–28. https://doi.org/10.1016/j.envres.2018.07.034.CrossRefPubMed

14.

Yang X, Jia X, Dong W, Wu S, Miller MR, Hu D, et al. Cardiovascular benefits of reducing personal exposure to traffic-related noise and particulate air pollution: a randomized crossover study in the Beijing subway system. Indoor Air. 2018;28(5):777–86. https://doi.org/10.1111/ina.12485.CrossRef

15.

Liu Y, Lan B, Shirai J, Austin E, Yang C, Seto E. Exposures to air pollution and noise from multi-modal commuting in a Chinese city. Int J Environ Res Public Health. 2019;16(14):2539. https://doi.org/10.3390/ijerph16142539.CrossRefPubMedCentral

16.

Shahidi F, Ambigaipalan P. Omega-3 polyunsaturated fatty acids and their health benefits. Annu Rev Food Sci Technol. 2018;9(1):345–81. https://doi.org/10.1146/annurev-food-111317-095850.CrossRefPubMed

17.

Calder PC. Omega-3 polyunsaturated fatty acids and inflammatory processes: nutrition or pharmacology? Br J Clin Pharmacol. 2013;75(3):645–62. https://doi.org/10.1111/j.1365-2125.2012.04374.x.CrossRefPubMedPubMedCentral

18.

Gutiérrez S, Svahn SL, Johansson ME. Effects of omega-3 fatty acids on immune cells. Int J Mol Sci. 2019;20(20):5028. https://doi.org/10.3390/ijms20205028.CrossRefPubMedCentral

19.

Yates CM, Calder PC, Ed RG. Pharmacology and therapeutics of omega-3 polyunsaturated fatty acids in chronic inflammatory disease. Pharmacol Ther. 2014;141(3):272–82. https://doi.org/10.1016/j.pharmthera.2013.10.010.CrossRefPubMed

20.

Bi X, Li F, Liu S, Jin Y, Zhang X, Yang T, et al. ω-3 polyunsaturated fatty acids ameliorate type 1 diabetes and autoimmunity. J Clin Invest. 2017;127(5):1757–71. https://doi.org/10.1172/jci87388.CrossRefPubMedPubMedCentral

21.

Brigham EP, Woo H, McCormack M, Rice J, Koehler K, Vulcain T, et al. Omega-3 and omega-6 intake modifies asthma severity and response to indoor air pollution in children. Am J Respir Crit Care Med. 2019;199(12):1478–86. https://doi.org/10.1164/rccm.201808-1474OC.CrossRefPubMedPubMedCentral

22.

Kampa M, Castanas E. Human health effects of air pollution. Environ Pollut. 2008;151(2):362–7. https://doi.org/10.1016/j.envpol.2007.06.012.CrossRefPubMed

23.

Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, et al. Multisociety consensus quality improvement revised consensus statement for endovascular therapy of acute ischemic stroke. Int J Stroke. 2018;13(6):612–32. https://doi.org/10.1177/1747493018778713.CrossRefPubMed

24.

Matthews NC, Pfeffer PE, Mann EH, Kelly FJ, Corrigan CJ, Hawrylowicz CM, et al. Urban particulate matter-activated human dendritic cells induce the expansion of potent inflammatory Th1, Th2, and Th17 effector cells. Am J Respir Cell Mol Biol. 2016;54(2):250–62. https://doi.org/10.1165/rcmb.2015-0084OC.CrossRefPubMedPubMedCentral

25.

Li Y, Zhou J, Rui X, Zhou L, Mo X. PM2.5 exposure exacerbates allergic rhinitis in mice by increasing DNA methylation in the IFN-γ gene promoter in CD4 + T cells via the ERK-DNMT pathway. Toxicol Lett. 2019;301:98–107. https://doi.org/10.1016/j.toxlet.2018.11.012.CrossRefPubMed

26.

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. https://doi.org/10.3758/bf03193146.CrossRefPubMed

27.

Mizota T, Fujita-Kambara C, Matsuya N, Hamasaki S, Fukudome T, Goto H, et al. Effect of dietary fatty acid composition on Th1/Th2 polarization in lymphocytes. JPEN J Parenter Enteral Nutr. 2009;33(4):390–6. https://doi.org/10.1177/0148607108325252.CrossRefPubMed

28.

Lin MT, Hsu CS, Yeh SL, Yeh CL, Chang KJ, Lee PH, et al. Effects of omega-3 fatty acids on leukocyte Th1/Th2 cytokine and integrin expression in rats with gut-derived sepsis. Nutrition. 2007;23(2):179–86. https://doi.org/10.1016/j.nut.2006.11.005.CrossRefPubMed

29.

Nakao M, Yamauchi K, Ishihara Y, Solongo B, Ichinnorov D, Breugelmans R. Validation of the Mongolian version of the SF-36v2 questionnaire for health status assessment of Mongolian adults. Springerplus. 2016;5(1):607. https://doi.org/10.1186/s40064-016-2204-7.CrossRefPubMedPubMedCentral

30.

Cherrie JW, Apsley A, Cowie H, Steinle S, Mueller W, Lin C, et al. Effectiveness of face masks used to protect Beijing residents against particulate air pollution. Occup Environ Med. 2018;75(6):446–52. https://doi.org/10.1136/oemed-2017-104765.CrossRefPubMed

31.

Dobreva ZG, Kostadinova GS, Popov BN, Petkov GS, Stanilova SA. Proinflammatory and anti-inflammatory cytokines in adolescents from Southeast Bulgarian cities with different levels of air pollution. Toxicol Ind Health. 2015;31(12):1210–7. https://doi.org/10.1177/0748233713491812.CrossRefPubMed

32.

Zhao C, Liao J, Chu W, Wang S, Yang T, Tao Y, et al. Involvement of TLR2 and TLR4 and Th1/Th2 shift in inflammatory responses induced by fine ambient particulate matter in mice. Inhal Toxicol. 2012;24(13):918–27. https://doi.org/10.3109/08958378.2012.731093.CrossRefPubMed

33.

Romagnani S. T-cell subsets (Th1 versus Th2). Ann Allergy Asthma Immunol. 2000;85(1):9–18; quiz 18, 21. https://doi.org/10.1016/s1081-1206(10)62426-x.CrossRefPubMed

34.

Rui W, Guan L, Zhang F, Zhang W, Ding W. PM2.5-induced oxidative stress increases adhesion molecules expression in human endothelial cells through the ERK/AKT/NF-κB-dependent pathway. J Appl Toxicol. 2016;36(1):48–59. https://doi.org/10.1002/jat.3143.CrossRefPubMed

35.

Hu H, Wu J, Li Q, Asweto C, Feng L, Yang X, et al. Fine particulate matter induces vascular endothelial activation via IL-6 dependent JAK1/STAT3 signaling pathway. Toxicol Res (Camb). 2016;5(3):946–53. https://doi.org/10.1039/c5tx00351b.CrossRefPubMedPubMedCentral

Title: Effect of omega-3 fatty acids on TH1/TH2 polarization in individuals with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study
Authors: Xiaomin Wang
Shuiqin Li
Yongcan Wu
Demei Huang
Caixia Pei
Yilan Wang
Shihua Shi
Fei Wang
Zhenxing Wang
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06091-5

2024 ASCO Annual Meeting

Springer Medicine

Effect of omega-3 fatty acids on TH1/TH2 polarization in individuals with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Abstract

Background

Methods

Discussion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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