The Plastic Exposure Reduction Transforms Health (PERTH) Trial
NCT Number: NCT06571994
Acronym: PERTH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endocrine Disruptors|Inflammation|Cardiometabolic Risk Factors
Interventions: BEHAVIORAL: Low Plastic Intervention
Sponsor: The University of Western Australia
Collaborators: The Minderoo Foundation
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2025-05-31
Locations: Harry Perkins Institute of Medical Research, Nedlands, Western Australia, 6009, Australia

Summary:
The goal of this randomized controlled trial is to learn if an intervention of reducing plastic exposure through diet, personal care and cleaning products can improve health outcomes in adult participants with cardiometabolic risk factors. The main questions it aims to answer are:

* Will the low plastic exposure intervention reduce urinary excretion of plastic-associated chemicals?
* Can reducing plastic exposure improve cardiometabolic biomarkers?
* Can reducing plastic exposure reduce inflammatory markers?

Researchers will compare this 28-day low plastic intervention with a control/no intervention group.

Participants in the intervention group will:

* be provided with food that have no/low plastic and plastic-associated chemicals
* be provided with personal care and cleaning produces that have no/low plastic and plastic-associated chemicals
* replace cooking and food preparation equipment with no/low plastic alternatives

Participants in the control group will not receive the intervention and are not expected to change their behaviour.

All participants will provide biological samples (urine, stool, nasal lavage and blood) at several timepoints during the study and attend 4 clinic visits: screening and before, during and after the intervention. Participants will also complete the sociodemographic questionnaire, a physical activity assessment using the International Physical Activity Questionnaire (IPAQ - Short Form), the 24-hr personal care product recall questionnaire, the plastic-associated chemicals questionnaire and be interviewed by a member of the research team to complete a 24-hour diet recall (24DR-PE) of food consumed, and how it was stored prepared, and consumed. The 24DR-PE will facilitate assessments of deviations from the protocol, and enable the assessment of energy, macro and micronutrient intake.

Primary Outcome Measures: Changes in urinary excretion of phthalates at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring concentrations (ng/mL) of metabolites from the following parent compounds of phthalates (diethyl phthalate, DEP; diisobutyl phthalate, DIBP; dibutyl phthalate, DBP; butyl benzyl phthalate, BBzP; Di-(2-Ethylhexyl) phthalate, DEHP; mono-(3-carboxypropyl) phthalate, MCPP) in urine samples, Baseline to 4 weeks for both groups|Changes in urinary excretion of bisphenols at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring concentrations (ng/mL) of bisphenol A (BPA) and bisphenol S (BPS) in urine samples, Baseline to 4 weeks for both groups
Secondary Outcome Measures: Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring fasting insulin (microU/L) x fasting glucose (nmol/L) / 22.5, in blood samples, Baseline to 4 weeks for both groups|Changes in body composition at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring fat mass, fat free mass, visceral adipose tissue, skeletal muscle mass, Baseline to 4 weeks for both groups|Changes in waist circumference at 4 weeks between participants in the low plastic intervention and control groups, Assessed using a non-stretchable tape measure waist circumference, Baseline to 4 weeks for both groups|Changes in blood pressure at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring systolic/diastolic blood pressure, Baseline to 4 weeks for both groups|Changes in triglyceride levels at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring triglycerides (mmol/L) in fasting blood samples, Baseline to 4 weeks for both groups|Changes in high sensitivity C-reactive protein (hsCRP) between participants in the low plastic intervention and control groups, Assessed by measuring fasted hsCRP (mg/L) in blood samples, Baseline to 4 weeks for both groups|Changes in adiponectin/leptin ratio at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring fasted adiponectin and lectin levels (pg/mL) in serum samples, Baseline to 4 weeks for both groups|Changes in liver function at 4 weeks between participants in the low plastic intervention and control groups, Assessed by measuring fasted alanine transaminase (ALT) and aspartate transaminase (AST) in blood samples, Baseline to 4 weeks for both groups