Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001259730
Ethics application status
Approved
Date submitted
1/09/2022
Date registered
20/09/2022
Date last updated
20/09/2022
Date data sharing statement initially provided
20/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Sources of Exposure to Plastic-Associated Chemicals (PAC) in People living in the Perth Region.
Scientific title
Sources of Exposure to Plastic-Associated Chemicals (PAC) in People living in the Perth Region.
Secondary ID [1] 307849 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The P.E.R.T.H (Plastic Exposure Reduction Transforms Health) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endocrine disruption 327498 0
Inflammation 327499 0
Condition category
Condition code
Inflammatory and Immune System 324617 324617 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will screen to recruit and retain an observational cohort of 200 adults who reside in the Perth Metropolitan Area. Once enrolled in the study, the participants, aged between 18-60 years, will attend two visits of up to two hours duration, over a 14-day period, at the Harry Perkins Research Institute (Nedlands, Western Australia).

At the first appointment (Visit 1, Time Point 1), which is anticipated to take up to two hours, the study doctor will carry out a health assessment including physical examination, medical history, and ECG. Anthropomorphic measurement will be carried out by the study nurse or dietitian. They will also be provided with a request form to attend their local pathology provider (in the fasting state) for health screening blood tests. Following clinician review of these results, and if screening is successful, the participant will be contacted and asked to attend a second appointment (Visit 2, Time Point 3). Conversely, if any de novo clinical abnormality is detected, the study doctor will write with the participant’s permission to their nominated General Practitioner. Participants will collect urine, stool and nasal lavage samples the day before (Time Point 2), the scheduled second visit (Visit 2, Time Point 3) scheduled to take place within 10 days of Visit 1.

At Visit 2, expected to take up to 2 hours, participants will have a blood sample taken, complete a sociodemographic questionnaire, two self-administered questionnaires; the 24-hr personal care product recall (24HR-PPR), and the Plastic Chemicals Exposure Questionnaire (PACeQ). Participants will be interviewed by a member of the research team to complete a 24-hour diet recall (24HR-DR) of food consumed, and how it was stored prepared, and consumed. At the end of this visit participants will be given sample containers and instructions to collect urine, stool and nasal lavage on the next Sunday (Time Point 4). The next day (Time Point 5), the participants will receive a telephone interview with the study dietitian using the 24HR-DR, and complete the 24HR-PPR via electronic survey. This interview is expected to take up to an hour. At the end of the 14-day observational study period participants will be sent a satisfaction survey via electronic survey. The survey is expected to take approximately 3 minutes to complete.

At this time, participants will be asked if they would be interested in participating in a 7-day pilot intervention study to investigate the impact of reduced PAC exposure. If affirmative, participants will be contacted when results of the assessments and urine tests have been analysed to confirm their suitability for a pilot intervention. This is estimated to be 2-3 months following recruitment.

Intervention code [1] 324315 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Active

Outcomes
Primary outcome [1] 332433 0
Presence of metabolites of plastic-associated chemicals (PAC) determined by urine analysis, from at least one of the two Time Points 2 and 4, reported for N=200 participants recruited.
Timepoint [1] 332433 0
Within four months after the last participant is enrolled in the trial.
Secondary outcome [1] 413714 0
Completed assessments for N=200 participants, evaluating exposure to plastic-associated chemicals using the trial specific Plastics Exposure Questionnaire (PACeQ).
Timepoint [1] 413714 0
At Time Point 3, within 12 days following enrolment.
Secondary outcome [2] 413715 0
Completed assessments for N=200 participants (at Timepoints 3 and 5), evaluating exposure to plastic-associated chemicals using the trial specific Personal Care Product recall questionnaire (24HR-PPR).
Timepoint [2] 413715 0
At Time Point 3 (within 12 days following enrolment) and Time Point 5 (14 days following enrolment).
Secondary outcome [3] 413716 0
Completed interviews for N=200 participants (at Time Points 3 and 5), evaluating dietary exposure to plastic-associated chemicals using the trial specific, 24-hour computer-assisted dietary recall interview (24HR-DR).
Timepoint [3] 413716 0
At Time Point 3 (within 12 days following enrolment) and Time Point 5 (14 days following enrolment).
Secondary outcome [4] 413863 0
The sensitivity of the trial-specific Plastics Exposure Questionnaire (PACeQ) as a measure of source exposure to PAC will be determined by comparison with the PAC urinalysis results.
Timepoint [4] 413863 0
Six months after the last participant is enrolled in the trial.
Secondary outcome [5] 413864 0
The sensitivity of the trial-specific Personal Care Product recall questionnaire (24HR-PPR) as a measure of source exposure to PAC will be determined by comparison with the PAC urinalysis results.
Timepoint [5] 413864 0
Six months after the last participant is enrolled in the trial.
Secondary outcome [6] 413865 0
The utility of the trial specific 24-hour computer-assisted, multi-pass, dietary recall interview (24HR-DR) as a measure of source exposure to PAC will be determined by comparison with the PAC urinalysis results.
Timepoint [6] 413865 0
Six months after the last participant is enrolled in the trial.
Secondary outcome [7] 413866 0
Overall satisfaction with the recruitment process assessed using the PERTH Trial Recruitment Satisfaction survey designed for the trial.
Timepoint [7] 413866 0
14 days after enrolment.

Eligibility
Key inclusion criteria
1. Healthy biological males or healthy, non-pregnant, non-lactating biological females aged 18 to 60 years.
2. Body mass index between greater than or equal to 18.5 and less than or equal to 34.9 kg/m2. If outside this range, eligible at investigator’s discretion.
3. Currently healthy (mentally and physically) in the opinion of the investigator based on a comprehensive clinical assessment (detailed medical history and physical examination), electrocardiogram (ECG), vital signs, and laboratory investigations (hematology, clinical chemistry, coagulation, and urinalysis).
4. Lives in the Perth Metropolitan Area.
5. Ability to give written informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as less than 21 units/week for males, and greater than 14/units for females.
2. 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.
3. Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
4. Not suitable for the study for any other reason, as determined by the investigator.
5. Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator’s discretion.
6. 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.
7. Clinically significant abnormal laboratory tests, as determined by the investigator, not otherwise mentioned.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis

The selection of N=200 as the optimal sample size is based on recommendations from the Clinical and Laboratory Standards Institute citing N=120 as the minimum number required for establishing reference intervals for laboratory testing. Using a confidence level of 95%, N=146 is determined to be the minimum needed. However, in order to account for the possibility of dropouts in the analysis, and the lack of any published data on plasticiser excretion in this population, N=200 is justifiable in the context of this study. Plastic-associated chemical excretion (PAC) will be summarised from urine results using means, standard deviations, and confidence intervals. Scores for the PACeQ, the 24HR-DR computer-assisted interview and the 24HR PPR will be validated against the PAC urinary excretion measures.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/10/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
28/05/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 38385 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312123 0
Charities/Societies/Foundations
Name [1] 312123 0
The Minderoo Foundation
Country [1] 312123 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 313645 0
None
Name [1] 313645 0
Address [1] 313645 0
Country [1] 313645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311522 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 311522 0
35 Stirling Hwy, Crawley WA 6009
Ethics committee country [1] 311522 0
Australia
Date submitted for ethics approval [1] 311522 0
08/06/2022
Approval date [1] 311522 0
18/08/2022
Ethics approval number [1] 311522 0
2021/ET001118

Summary
Brief summary
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 antecedent cluster of risk factors contributes to a ‘pre-cardiometabolic syndrome’.

In this trial, the first of a series of studies, we will measure the plastic-associated chemicals (PAC), phthalates and bisphenols (A, S, F), which leach from multiple plastic products in everyday use and enter the human body, as evidenced by urinary excretion of those chemicals. The challenge is to demonstrate that decreasing exposure to PAC will reduce inflammation, and there are methodological issues to overcome which we will address in this study. Including how to accurately identify sources of exposure and measure exposure levels, and how to identify the mechanisms by which PAC alter biomarkers at a cellular level triggering endocrine disruption. In addition, biostatistical methods will be applied to account for multiple and overlapping interactions, and exposures to chemical compounds.

This protocol will establish methods to assess exposure using new tools, and measurement of PAC by urinalysis. The data gathered from the 200 participants in this 14-day study will provide baseline data for a pilot intervention testing the hypothesis that decreasing PAC exposure results in reduced excretion of PAC, and reference data for future research.
Trial website
Trial related presentations / publications
Public notes
At the time of recruitment, proof of immunisation against COVID_19 (SARS-CoV-2), will be required according to WA Health Department Guidelines.

Contacts
Principal investigator
Name 121394 0
Prof Michaela Lucas
Address 121394 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121394 0
Australia
Phone 121394 0
+61 466553256
Fax 121394 0
Email 121394 0
Michaela.Lucas@uwa.edu.au
Contact person for public queries
Name 121395 0
Prof Michaela Lucas
Address 121395 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121395 0
Australia
Phone 121395 0
+61 466 553 256
Fax 121395 0
Email 121395 0
Michaela.Lucas@uwa.edu.au
Contact person for scientific queries
Name 121396 0
Prof Michaela Lucas
Address 121396 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121396 0
Australia
Phone 121396 0
+61 466553256
Fax 121396 0
Email 121396 0
Michaela.Lucas@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage of the study we will not make the decision on sharing IPD but this decision may be reviewed in the future.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.