Lucas Andrew, Harray Amelia, Duong Lelinh, Herrmann Susan, Vlaskovsky Philip, Trevenen Michelle, Chan Dick, Papendorf Hannah, Smith Tony, Flint Lilith, Liu Alex, Gaudieri Silvana, Wang Xianyu, Mueller Jochen F, Thomas Kevin V, Murray Kevin, Symeonides Christos, Dunlop Sarah, Watts Gerald, Lucas Michaela
School of Biomedical Sciences, The University of Western Australia, Nedlands, Western Australia, Australia.
Medical School, The University of Western Australia, Nedlands, Western Australia, Australia.
BMJ Open. 2025 Aug 25;15(8):e099330. doi: 10.1136/bmjopen-2025-099330.
Phthalates and bisphenols, chemicals commonly used in the production of plastic products, exhibit endocrine disrupting properties linked to obesity and systemic inflammation. Given the ubiquitous use of plastic chemicals, their adverse impact on human health is of great importance. In this protocol, we describe a randomised controlled trial aimed at testing whether minimising exposure to plastics and plastic-associated chemicals (PACs) in community-dwelling adults with cardiometabolic risk factors can reduce urinary excretion of PACs and improve cardiometabolic health.
The study will recruit (n=60) community-dwelling adults (18-60 years) with cardiometabolic risk factors, characterised by a body mass index of ≥30 kg/m and waist circumference of ≥88 cm in women and ≥102 cm in men. Participants will be randomised to a control (n=30) or an intervention group (n=30) receiving a 4-week diet and lifestyle modification designed to reduce plastic exposure, which includes the replacement of all food, kitchen utensils and equipment, personal care and cleaning products. The primary outcome is a reduction in urinary excretion of bisphenols after the 4-week intervention compared with the control arm. The secondary outcomes are the reduction in urinary excretion of low and high molecular weight phthalates. Finally, tertiary outcomes investigate improvements to cardiometabolic biomarkers, body composition, waist circumference and blood pressure. Participants will self-collect urine, stool and nasal lavage samples a day before beginning the intervention and at the end of each week. Fasting blood samples and health assessments will be collected during clinic visits: at baseline, mid-point and a day after the intervention period. Urinary PAC excretion and cardiometabolic health outcomes will be compared between the intervention and control groups.
The PERTH Trial has ethics approval from the University of Western Australia Human Research Ethics Committee; 2021-ET001118. Results will be submitted for publication in peer-reviewed journals and presented at conferences.
NCT06571994.
邻苯二甲酸盐和双酚是塑料制品生产中常用的化学物质，具有与肥胖和全身炎症相关的内分泌干扰特性。鉴于塑料化学物质的广泛使用，它们对人类健康的不利影响至关重要。在本方案中，我们描述了一项随机对照试验，旨在测试在有心脏代谢风险因素的社区居住成年人中，尽量减少接触塑料和塑料相关化学物质（PACs）是否能减少PACs的尿液排泄并改善心脏代谢健康。
该研究将招募（n = 60）有心脏代谢风险因素的社区居住成年人（18至60岁），其特征为女性体重指数≥30 kg/m²且腰围≥88 cm，男性体重指数≥30 kg/m²且腰围≥102 cm。参与者将被随机分为对照组（n = 30）或干预组（n = 30），干预组接受为期4周的旨在减少塑料接触的饮食和生活方式改变，包括更换所有食品、厨具和设备、个人护理及清洁产品。主要结局是与对照组相比，4周干预后双酚尿液排泄量的减少。次要结局是低分子量和高分子量邻苯二甲酸盐尿液排泄量的减少。最后，三级结局研究心脏代谢生物标志物、身体成分、腰围和血压的改善情况。参与者将在干预开始前一天以及每周结束时自行采集尿液、粪便和鼻腔灌洗样本。在门诊就诊期间（基线、中期和干预期结束后一天）采集空腹血样和进行健康评估。将比较干预组和对照组之间的尿液PAC排泄量和心脏代谢健康结局。
珀斯试验已获得西澳大利亚大学人类研究伦理委员会的伦理批准；2021 - ET001118。研究结果将提交至同行评审期刊发表，并在会议上展示。
NCT06571994。
