Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571994
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
The Plastic Exposure Reduction Transforms Health Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Effect of Minimal Plastics Exposure on Plastic-Associated Chemicals PAC Excretion and Biomarkers in Adults with Cardiometabolic Risk Factors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERTH
Brief 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 plastic-associated chemicals
Can reducing plastic exposure improve cardiometabolic biomarkers
Can reducing plastic exposure reduce inflammatory markers
Researchers will compare this 28-day low plastic intervention with a controlno intervention group
Participants in the intervention group will
be provided with food that have nolow plastic and plastic-associated chemicals
be provided with personal care and cleaning produces that have nolow plastic and plastic-associated chemicals
replace cooking and food preparation equipment with nolow 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
Will the low plastic exposure intervention reduce urinary excretion of plastic-associated chemicals
Can reducing plastic exposure improve cardiometabolic biomarkers
Can reducing plastic exposure reduce inflammatory markers
Researchers will compare this 28-day low plastic intervention with a controlno intervention group
Participants in the intervention group will
be provided with food that have nolow plastic and plastic-associated chemicals
be provided with personal care and cleaning produces that have nolow plastic and plastic-associated chemicals
replace cooking and food preparation equipment with nolow 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
Detailed Description:
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 N60 will be randomized to one of two parallel groups to receive a 28-day low plastic intervention in their homes with the support of registered dietitians
Group 1 N30 low plastic intervention group
Group 2 N30 controlno intervention group
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 videophone appointment between screening and Visit 1
The day before and after the videophone appointment participants will be asked to collect urine stool and nasal washing samples and send them back the day after their videophone appointment At the end of the videophone 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 videophone 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 28-day intervention
All participants will be asked to collect urine stool and nasal washing samples on days 0 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 28-day 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 28-day intervention The questionnaire consists of 15 questions and will take between 2 and 5 minutes to complete
A post-trial survey will be conducted to identify any difficulties experienced by the participants that might have affected their adherence to the intervention and procedures
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 N60 will be randomized to one of two parallel groups to receive a 28-day low plastic intervention in their homes with the support of registered dietitians
Group 1 N30 low plastic intervention group
Group 2 N30 controlno intervention group
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 videophone appointment between screening and Visit 1
The day before and after the videophone appointment participants will be asked to collect urine stool and nasal washing samples and send them back the day after their videophone appointment At the end of the videophone 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 videophone 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 28-day intervention
All participants will be asked to collect urine stool and nasal washing samples on days 0 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 28-day 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 28-day intervention The questionnaire consists of 15 questions and will take between 2 and 5 minutes to complete
A post-trial survey will be conducted to identify any difficulties experienced by the participants that might have affected their adherence to the intervention and procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None