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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

Titles & IDs
Public title
The Plastic Exposure Reduction Transforms Health Trial
Scientific title
Examining the Effect of Minimal Plastics Exposure on Plastic-Associated Chemicals (PAC) Excretion and Biomarkers in Adults with Cardiometabolic Risk Factors
Secondary ID [1] 0 0
2021_ET001118
Universal Trial Number (UTN)
Trial acronym
PERTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endocrine Disruptors 0 0
Inflammation 0 0
Cardiometabolic Risk Factors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 28-day intervention.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in urinary excretion of plastic-associated chemicals (composite of mono-n-butyl phthalate, MnBP; mono benzyl phthalate, MBzP; and bisphenol A, BPA)
Timepoint [1] 0 0
Baseline and 4 weeks for both groups
Secondary outcome [1] 0 0
Changes in urinary excretion of mono-n-butyl phthalate (MnBP)
Timepoint [1] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [2] 0 0
Changes in urinary excretion of mono benzyl phthalate (MBzP)
Timepoint [2] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [3] 0 0
Changes in urinary excretion of mono ethyl phthalate (MEP)
Timepoint [3] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [4] 0 0
Changes in urinary excretion of mono-iso-butyl phthalate (MiBP)
Timepoint [4] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [5] 0 0
Changes in urinary excretion of mono-n-octyl phthalate (MnOP)
Timepoint [5] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [6] 0 0
Changes in urinary excretion of di-(2-ethylhexyl) phthalate (DEHP)
Timepoint [6] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [7] 0 0
Changes in urinary excretion of bisphenol A (BPA)
Timepoint [7] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [8] 0 0
Changes in urinary excretion of bisphenol F (BPF)
Timepoint [8] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [9] 0 0
Changes in urinary excretion of bisphenol S (BPS)
Timepoint [9] 0 0
Baseline, and 1, 2, 3 and 4 weeks for both groups
Secondary outcome [10] 0 0
Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Timepoint [10] 0 0
Baseline, and 2 and 4 weeks for both groups
Secondary outcome [11] 0 0
Changes in fasting serum triglycerides
Timepoint [11] 0 0
Baseline, and 2 and 4 weeks for both groups
Secondary outcome [12] 0 0
Changes in high sensitivity C-reactive protein (hsCRP)
Timepoint [12] 0 0
Baseline, and 2 and 4 weeks for both groups
Secondary outcome [13] 0 0
Changes in body composition
Timepoint [13] 0 0
Baseline, and 2 and 4 weeks for both groups
Secondary outcome [14] 0 0
Changes in waist circumference
Timepoint [14] 0 0
Baseline, and 2 and 4 weeks for both groups
Secondary outcome [15] 0 0
Changes in blood pressure
Timepoint [15] 0 0
Baseline, and 2 and 4 weeks for both groups

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Harry Perkins Institute of Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Minderoo Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michaela Lucas
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michaela Lucas
Address 0 0
Country 0 0
Phone 0 0
+61 08 6151 1010
Fax 0 0
Email 0 0
michaela.lucas@uwa.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage of the study the investigators do not plan to share IPD but this decision may be reviewed in the future.


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