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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06571994
Registration number
NCT06571994
Ethics application status
Date submitted
31/07/2024
Date registered
26/08/2024
Date last updated
25/03/2025
Titles & IDs
Public title
The Plastic Exposure Reduction Transforms Health Trial
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Scientific title
Examining the Effect of Minimal Plastics Exposure on Plastic-Associated Chemicals (PAC) Excretion and Biomarkers in Adults with Cardiometabolic Risk Factors
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Secondary ID [1]
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2021_ET001118
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Universal Trial Number (UTN)
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Trial acronym
PERTH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endocrine Disruptors
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Inflammation
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Cardiometabolic Risk Factors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Low Plastic Intervention
Experimental: Low Plastic Intervention Group - 30 participants randomly assigned to the intervention group will consume low PAC food, employ low risk PAC food preparation practices, and use low PAC personal care and cleaning products.
No intervention: Control Group - 30 participants randomly assigned to the control group will not receive the intervention nor expected to change behaviour.
BEHAVIORAL: Low Plastic Intervention
Participants will be provided with food that contain no or low plastic and PAC. This is defined as minimally processed (according to NOVA Classification) fresh produce where the supply chain is either known to be free, or likely to be free of plastic contamination. Foods that are canned, pickled, use plastic storage containers will be either avoided or substituted where possible with glass. Participants will also follow guidance concerning the preparation of their food. Plastic utensils used in the preparation of food will be substituted for non-plastic. Commonly used personal care products, e.g., shampoo and soaps, and cleaning products will be replaced with no/low PAC alternatives. Participants will be supplied with a comprehensive schedule, and instructions for the 4-week intervention.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in bisphenols (composite of bisphenol A, BPA; and bisphenol S, BPS)
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Assessment method [1]
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Assessed by measuring urinary concentrations (ng/mL) of BPA and BPS and comparing mean percent change
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Timepoint [1]
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Baseline and 4 weeks for both groups
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Secondary outcome [1]
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Change in bisphenol A (BPA)
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Assessment method [1]
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Assessed by measuring urinary concentrations BPA (ng/mL) and compare mean percent change
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Timepoint [1]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [2]
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Change in bisphenol S (BPS)
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Assessment method [2]
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Assessed by measuring urinary concentrations of BPS (ng/mL) and compare mean percent change
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Timepoint [2]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [3]
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Change in diethyl phthalate (DEP)
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Assessment method [3]
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Assessed by measuring urinary concentrations (ng/mL) of DEP metabolite, mono-ethyl phthalate (MEP), and compare mean percent change
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Timepoint [3]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [4]
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Change in di-n-butyl-phthalate (DnBP)
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Assessment method [4]
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Assessed by measuring urinary concentrations (ng/mL) of DnBP metabolites, mono-n-butyl-phthalate (MnBP) and mono-(3-carboxypropyl) phthalate (MCPP), and compare mean percent change
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Timepoint [4]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [5]
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Change in di-iso-butyl phthalate (DiBP)
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Assessment method [5]
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Assessed by measuring urinary concentrations (ng/mL) of DiBP metabolite, mono-iso-butyl phthalate (MiBP), and compare mean percent change
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Timepoint [5]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [6]
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Change in benzyl butyl phthalate (BBP)
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Assessment method [6]
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Assessed by measuring urinary concentrations (ng/mL) of BBP metabolite, mono-benzyl phthalate (MBzP), and compare mean percent change
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Timepoint [6]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Secondary outcome [7]
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Change in di-(2-ethylhexyl) phthalate (DEHP)
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Assessment method [7]
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Assessed by measuring urinary concentrations (ng/mL) of the composite of DEHP metabolites (mono-2-ethylhexyl phthalate, MEHP; mono-(2-ethyl-5-oxohexyl) phthalate, MEOHP; mono-(2-ethyl-5-hydroxyhexyl) phthalate, MEHHP; and mono-(2-ethyl-5-carboxypentyl) phthalate, MECPP) and compare mean percent change
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Timepoint [7]
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Baseline, and 1, 2, 3 and 4 weeks for both groups
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Eligibility
Key inclusion criteria
1. Biological males or, non-pregnant, non-lactating biological females aged 18 to 60 years.
a) For female participants at least one of the following must apply: i) Not of childbearing potential - surgical sterile or postmenopausal (no menses last 12 months and follicle-stimulating hormone (FSH) greater than 40 mIU/mL); ii) Childbearing potential and agrees to practice true abstinence, is in a same-sex relationship or agrees to use effective contraception during the study (either hormonal contraception, intrauterine devices or condom) or has a vasectomised male partner.
2. Body mass index =30 kg/m2. If outside this range, eligible at investigator's discretion.
3. Waist circumference =102cm in men and =88cm in women. If outside this range, eligible at investigator's discretion.
4. Certain medications may be excluded based on investigators discretion.
5. Lives in the Perth Metropolitan Area.
6. Willing to change all they eat, not eat out and not wear makeup for 4 weeks if selected for intervention.
7. Ability to give written informed consent.
8. Proof of immunisation against COVID-19 (SARS-CoV-2), according to WA Health guidelines at time of recruitment.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Any abnormalities in electrocardiogram (ECG) readings, or as per the Investigator's discretion.
2. History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as greater than 21 units/week for males, greater than 14 units/week for females.
3. Current regular smoker or e-cigarette use. Social smokers (less than 3 nicotine/tobacco products in the last 3 months) can be included if abstaining for the duration of the study.
4. Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
5. Currently on, or within 3 months of discontinuing, glucagon-like peptide-1 agonists or related compounds. If inside this range, eligible at Investigator's discretion.
6. Living in a home that has been renovated in the past 4-weeks.
7. Have known severe food allergies or anaphylaxis to common food allergens. As per the Investigator's discretion.
8. Not suitable for the study for any other reason, as determined by the investigator.
9. Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator's discretion.
10. Evidence of moderate or greater renal impairment at screening, as indicated by an estimated creatinine clearance of less than 60 mL/min using the Cockcroft-Gault equation.
11. Clinically significant abnormal laboratory tests or examination findings, as determined by the investigator, not otherwise mentioned.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Harry Perkins Institute of Medical Research - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Minderoo Foundation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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 bisphenols? * Will the low plastic exposure intervention reduce urinary excretion of phthalate metabolites? * Can reducing plastic exposure improve cardiometabolic biomarkers? Researchers will compare this 4-week 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.
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Trial website
https://clinicaltrials.gov/study/NCT06571994
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michaela Lucas
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Michaela Lucas
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Address
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Country
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Phone
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+61 08 6151 1010
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06571994
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