Examining the effect of minimal plastics exposure strategies on Plastic-Associated Chemicals (PAC) Excretion in healthy adults.

Not Applicable

• Conditions: Inflammatory and Immune System - Other inflammatory or immune system disorders; Endocrine disruption; Inflammation

• Registration Number: ACTRN12622001252707
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-19
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Healthy biological males or healthy, non-pregnant, non-lactating biological females aged 18 to 60 years.
a. For female participants at least one of the following must apply
b. Not of childbearing potential – surgical sterile or postmenopausal (no menses last 12 months and FSH greater than 40 mIU/mL)
c. Childbearing potential and agrees to practice true abstinence, is in a same-sex relationship or agrees to use highly effective contraception during the course of the study (hormonal contraception with condom/IUD) or vasectomised male partner.
2. Body mass index between less than or equal to 18.5 and greater 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.

Exclusion Criteria

1. 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 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of the intervention study as evidenced by an audit of the study database indicating complete ascertainment of data from 60 participants. [Three months following commencement of the trial. ]

Secondary Outcome Measures

Name	Time	Method
Completed evaluation of the 24-hour computer-assisted dietary recall interview (24HR-DR) as evidenced by an audit of the study database.[Three months following the commencement of the trial.];Presence of metabolites of plastic-associated chemicals (PAC) determined by urine analysis reported for N=60 participants recruited.[Six months following commencement of the trial.];Tolerability and feasibility of the interventions is indicated by data gathered from individual semi-structured telephone interviews between researchers and participants.[Four months after the commencement of the study.]