The Plastic Exposure Reduction Transforms Health Trial (NCT06571994) | Clinical Trial Compass
CompletedNot Applicable
The Plastic Exposure Reduction Transforms Health Trial
Australia60 participantsStarted 2024-09-05
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Biological males or, non-pregnant, non-lactating biological females aged 18 to 60 years.
✓. 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 criteria
✕. Any abnormalities in electrocardiogram (ECG) readings, or as per the Investigator's discretion.
What they're measuring
1
Change in bisphenols (composite of bisphenol A, BPA; and bisphenol S, BPS)
. 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.