Reducing plastic exposure to improve health outcomes

Examining the Effect of Minimal Plastics Exposure on Plastic-Associated Chemicals (PAC) Excretion and Biomarkers in Adults with Cardiometabolic Risk Factors

This study is testing if reducing plastic exposure through diet and personal care products can help improve health in adults at risk for heart and metabolic issues.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: The University of Western Australia (Academic / other)
• Locations: 1 site (Nedlands, Western Australia)
• Trial ID: NCT06571994 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial investigates whether a 4-week intervention aimed at reducing plastic exposure through dietary changes and the use of low plastic personal care and cleaning products can improve health outcomes in adults with cardiometabolic risk factors. Participants will be divided into two groups: one receiving the low plastic intervention and the other serving as a control group with no intervention. The study will measure changes in urinary excretion of bisphenols and phthalate metabolites, as well as improvements in cardiometabolic biomarkers. The intervention will be supported by registered dietitians and will include in-person clinic appointments for monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a body mass index of 30 or higher and waist circumference measurements indicating cardiometabolic risk.

Not a fit: Patients who are not within the specified age range, do not meet the body mass index or waist circumference criteria, or are not willing to adhere to the dietary and lifestyle changes may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to significant improvements in health outcomes for individuals at risk of cardiometabolic diseases by reducing harmful plastic exposure.

How similar studies have performed: While the specific approach of reducing plastic exposure is novel, related studies have indicated that reducing exposure to endocrine disruptors can have positive health outcomes.

Eligibility criteria

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.

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.

Where this trial is running

Nedlands, Western Australia

• Harry Perkins Institute of Medical Research — Nedlands, Western Australia, Australia (Recruiting)

Study contacts

• Principal investigator: Michaela Lucas — The University of Western Australia
• Study coordinator: Michaela Lucas

Conditions Endocrine Disruptors; Inflammation; Cardiometabolic Risk Factors; Plastic; Microplastic; Nanoplastic; Plastic associated chemicals; Bisphenols