An interventional study of Low Plastic Intervention in Endocrine Disruptors, Inflammation and Cardiometabolic Risk Factors, sponsored by The University of Western Australia. Completed at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by The University of Western Australia · Not applicable, Interventional, and Prevention
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:
Researchers will compare this 4-week low plastic intervention with a control/no intervention group.
Participants in the intervention group will:
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.
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 human body. Food contaminated from packaging or with plastic particles, personal care and cleaning products may be sources of PAC which can be inhaled or absorbed through the skin. The fundamental premise underpinning the research is that exposure to PAC, combined with genetic and lifestyle factors, creates chronic and systemic inflammation that underpins cardiometabolic conditions.
This randomized controlled trial aims to demonstrate whether decreasing exposure to plastic and PAC will reduce urinary excretion of PAC and improve cardiometabolic biomarkers in people with cardiometabolic risk factors.
Participants that have consented and passed health screening (N=60) will be randomized to one of two parallel groups, to receive a 4-week low plastic intervention in their homes with the support of registered dietitians.
All participants will attend four in-person clinic appointments, one during screening, and three during the intervention (Visit 1: day 0, baseline; Visit 2: day 16, midpoint; and Visit 3: day 29, post intervention), of up to two hours duration each. In addition, participants will have a video/phone appointment between screening and Visit 1.
The day before and after the video/phone appointment, participants will be asked to collect urine, stool and nasal washing samples and send them back the day after their video/phone appointment. At the end of the video/phone appointment, eligible and willing participants will be invited to continue to the intervention study and randomized into either the intervention or control group. At the video/phone appointment, participants from Group 1 will order their food and personal care products. The researchers will send the order to a local meal service delivery who will order, pay for, package, and deliver the approved food to the participants' homes in insulated boxes. Delivery of approved products to participants' homes will take place the day before the intervention begins, and at other pre-determined timepoints throughout the study, as required. Samples of food products will be frozen for retrospective testing for PAC, if exposure testing indicates contamination from an unexpected source. Participants from Group 1 will use only non-plastic cooking utensils provided by the researchers and follow guidance concerning the preparation of their food. Participants from Group 1 will use only personal care and cleaning products supplied by the research team. Personal care products include, but are not limited to shampoo, conditioners, face moisturizers, cleansers, serums, make-up and sunscreens, deodorant, tampons and applicators. Participants will be supplied with a comprehensive schedule, and instructions for the 4-week intervention.
All participants will be asked to collect urine, stool, and nasal washing samples on days -1, 8, 15, 22 and 28 of the intervention period, and return them at the clinic visits. During the clinic visits, participants will have fasting blood sample taken, 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 - plastic exposure (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.
For intervention adherence the following assessment tools will be employed:
24-hour dietary recall - plastic exposure interview (24DR-PE): This assessment is a researcher-administered, computer-assisted, 24-hour dietary recall interview. The method assesses dietary intake on the preceding 24-hour period. The method is adapted to gather additional information concerning the packaging, storage, and preparation of food by the participants. Trained dietitians will carry out the interviews during the clinic visits. The interviews will vary in length between 15 and 60 minutes depending on the stage of the study, and the complexity of each participants' diet. They will be carried out once during screening and three times during the 4-week intervention.
24-hour personal care product recall (24HR-PPR): This is a self-administered questionnaire for the 24-hour recall of personal care products use. This assessment will be conducted once during screening and three times during the 4-week intervention. The questionnaire consists of 15 questions and will take between 2 and 5 minutes to complete.
Post-trial survey: This survey will be conducted to identify any difficulties experienced by the participants that might have affected their adherence to the intervention and procedures.
Tolerability and feasibility qualitative interview: To evaluate the tolerability and feasibility of the trial intervention, participants will be invited to participate in a phone interview within two weeks of completing the intervention. A trained interviewer will conduct the interviews using a structured guide that includes both closed and open-ended questions. Each interview is expected to last 20-40 minutes.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →The University of Western Australia is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 - surgical sterile or (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 during the study (either hormonal contraception, intrauterine devices or condom) or has a vasectomised male partner.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
30 participants randomly assigned to the control group will not receive the intervention nor expected to change behaviour.
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.
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
Time frame: Baseline and 4 weeks for both groups
Change in bisphenol A (BPA)
Assessed by measuring urinary concentrations BPA (ng/mL) and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in bisphenol S (BPS)
Assessed by measuring urinary concentrations of BPS (ng/mL) and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in diethyl phthalate (DEP)
Assessed by measuring urinary concentrations (ng/mL) of DEP metabolite, mono-ethyl phthalate (MEP), and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in di-n-butyl-phthalate (DnBP)
Assessed by measuring urinary concentrations (ng/mL) of DnBP metabolites, mono-n-butyl-phthalate (MnBP) and mono-(3-carboxypropyl) phthalate (MCPP), and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in di-iso-butyl phthalate (DiBP)
Assessed by measuring urinary concentrations (ng/mL) of DiBP metabolite, mono-iso-butyl phthalate (MiBP), and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in benzyl butyl phthalate (BBP)
Assessed by measuring urinary concentrations (ng/mL) of BBP metabolite, mono-benzyl phthalate (MBzP), and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Change in di-(2-ethylhexyl) phthalate (DEHP)
Assessed by measuring urinary concentrations (ng/mL) of the composite of DEHP metabolites (mono-2-ethylhexyl phthalate, MEHP; mono-(2-ethyl-5-oxohexyl) phthalate, MEOHP; mono-(2-ethyl-5-hydroxyhexyl) phthalate, MEHHP; and mono-(2-ethyl-5-carboxypentyl) phthalate, MECPP) and compare mean percent change
Time frame: Baseline, and 1, 2, 3 and 4 weeks for both groups
Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Assessed by measuring glucose (mmol/L) x insulin (mU/L / 22.5 in fasting blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in fasting serum triglycerides
Assessed by measuring triglycerides (mmol/L) in fasting blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in high sensitivity C-reactive protein (hsCRP)
Assessed by measuring hsCRP (mg/L) in fasting blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in cholesterol
Assessed by measuring low-density lipoprotein cholesterol (LDL-C; mmol/L), high-density lipoprotein cholesterol (HDL-C; mmol/L) and remnant cholesterol (mmol/L) in fasting blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in liver function
Assessed by measuring fasted alanine transaminase (ALT) and aspartate transaminase (AST) in blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in renal function
Assessed by measuring estimated glomerular filtration rate (mL/min/1.73 m2) using age, sex and plasma/serum creatinine
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in adiponectin/leptin ratio
Assessed by measuring adiponectin and leptin levels (pg/mL) in fasting blood samples
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in body composition
Assessed by measuring mass, fat free mass, visceral adipose tissue, and skeletal muscle mass
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in waist circumference
Assessed by using a non-stretchable tape measure to obtain waist circumference
Time frame: Baseline, and 2 and 4 weeks for both groups
Changes in blood pressure
Assessed by measuring systolic/diastolic blood pressure
Time frame: Baseline, and 2 and 4 weeks for both groups
Plan to share: No — At this stage of the study the investigators do not plan to share IPD but this decision may be reviewed in the future.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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