The Plastic Exposure Reduction Transforms Health Trial

NCT06571994 | Completed DMC

• 1 other identifier: 2021_ET001118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocrine Disruptors; Inflammation; Cardiometabolic Risk Factors

Keywords

Plastic; Microplastic; Nanoplastic; Plastic associated chemicals; Bisphenols; Phthalates; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in bisphenols (composite of bisphenol A, BPA; and bisphenol S, BPS)

  Assessed by measuring urinary concentrations (ng/mL) of BPA and BPS and comparing mean percent change

  Baseline and 4 weeks for both groups

Secondary Outcomes (7)

• Change in bisphenol A (BPA)

  Baseline, and 1, 2, 3 and 4 weeks for both groups

• Change in bisphenol S (BPS)

  Baseline, and 1, 2, 3 and 4 weeks for both groups

• Change in diethyl phthalate (DEP)

  Baseline, and 1, 2, 3 and 4 weeks for both groups

• Change in di-n-butyl-phthalate (DnBP)

  Baseline, and 1, 2, 3 and 4 weeks for both groups

• Change in di-iso-butyl phthalate (DiBP)

  Baseline, and 1, 2, 3 and 4 weeks for both groups

Other Outcomes (10)

• Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Baseline, and 2 and 4 weeks for both groups

• Changes in fasting serum triglycerides

  Baseline, and 2 and 4 weeks for both groups

• Changes in high sensitivity C-reactive protein (hsCRP)

  Baseline, and 2 and 4 weeks for both groups

Study Arms (2)

Low Plastic Intervention Group

EXPERIMENTAL

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.

Behavioral: Low Plastic Intervention

Control Group

NO INTERVENTION

30 participants randomly assigned to the control group will not receive the intervention nor expected to change behaviour.

Interventions

Low Plastic Intervention BEHAVIORAL

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.

Low Plastic Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Western Australia: lead
• The Minderoo Foundation: collaborator

Study Sites (1)

Harry Perkins Institute of Medical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

• Lucas A, Harray A, Duong L, Herrmann S, Vlaskovsky P, Trevenen M, Chan D, Papendorf H, Smith T, Flint L, Liu A, Gaudieri S, Wang X, Mueller JF, Thomas KV, Murray K, Symeonides C, Dunlop S, Watts G, Lucas M. Randomised controlled trial of a low plastic diet and lifestyle intervention for adults with cardiometabolic risk factors: the Plastic Exposure Reduction Transforms Health (PERTH) trial - a protocol. BMJ Open. 2025 Aug 25;15(8):e099330. doi: 10.1136/bmjopen-2025-099330.

  PMID: 40854835 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michaela Lucas

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statisticians and laboratory personnel involved in analysis of the biological samples will be blinded to participant status
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 26, 2024
• Study Start: September 5, 2024
• Primary Completion: July 3, 2025
• Study Completion: July 4, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)