None listed
Conditions
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.
Interventions
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 physi
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.
Sponsors
The University of Western Australia
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed