Status:
COMPLETED
The Plastic Exposure Reduction Transforms Health Trial
Lead Sponsor:
The University of Western Australia
Collaborating Sponsors:
The Minderoo Foundation
Conditions:
Endocrine Disruptors
Inflammation
Eligibility:
All Genders
18-60 years
Phase:
NA
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 particip...
Detailed Description
Many plastic products contain endocrine disrupting chemicals, such as bisphenols and phthalates (referred to as plastic-associated chemicals or PAC), which leach out from everyday use and enter the hu...
Eligibility Criteria
Inclusion
- 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.
- Body mass index ≥30 kg/m2. If outside this range, eligible at investigator's discretion.
- Waist circumference ≥102cm in men and ≥88cm in women. If outside this range, eligible at investigator's discretion.
- Certain medications may be excluded based on investigators discretion.
- Lives in the Perth Metropolitan Area.
- Willing to change all they eat, not eat out and not wear makeup for 4 weeks if selected for intervention.
- Ability to give written informed consent.
- Proof of immunisation against COVID-19 (SARS-CoV-2), according to WA Health guidelines at time of recruitment.
Exclusion
- Any abnormalities in electrocardiogram (ECG) readings, or as per the Investigator's discretion.
- 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.
- 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.
- Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
- 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.
- Living in a home that has been renovated in the past 4-weeks.
- Have known severe food allergies or anaphylaxis to common food allergens. As per the Investigator's discretion.
- Not suitable for the study for any other reason, as determined by the investigator.
- Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator's discretion.
- 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.
- Clinically significant abnormal laboratory tests or examination findings, as determined by the investigator, not otherwise mentioned.
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06571994
Start Date
September 5 2024
End Date
July 4 2025
Last Update
December 22 2025
Active Locations (1)
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1
Harry Perkins Institute of Medical Research
Nedlands, Western Australia, Australia, 6009