The Plastic Exposure Reduction Transforms Health Trial

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

Interventions

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.

Sponsors & Collaborators

• The Minderoo Foundation

  collaborator UNKNOWN

• The University of Western Australia

  lead OTHER

Principal Investigators

• Michaela Lucas · The University of Western Australia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-05

Primary Completion

2025-07-03

Completion

2025-07-04

Countries

• Australia

Study Locations