Dietary ExposureBIOFOODPACKNCT04963842
Investigation on the Benefits of Avoiding Conventional Food Packaging and Promoting Bioplastic Food Packaging
A study testing Use of bio-plastic food packaging material and avoidance of plastic food packaging material in people with Dietary Exposure, run by Cyprus University of Technology at 1 site in Cyprus.
Trial summary
A trial study was proposed as part of the project "Biocomposite Packaging for Active Preservation of Food" (acronym BIOFOODPACK) that has been funded by the M-ERA.Net Call 2016. A crossover trial with a behavioral intervention study will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Use of bio-plastic food packaging material and avoidance of plastic food packaging material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jul 2021to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ηealthy young women at the age of 18-40 years old, who reside in Cyprus at least the last five years. Also, subjects will be included if they routinely consume food previously packaged in plastic packaging materials/boxes
Who cannot join
- Women with medical history, such as those taking medication for any chronic disease such as asthma, type I diabetes and those who systematically don't use or buy plastic packaged food.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining the Effects of Avoiding the Consumption of Packaged Food and Promoting the Use of Bioplastic Food Packaging on the Body Burden of Plasticizers in Young Women: A Pilot Cross-over Study
A trial study was proposed as part of the project "Biocomposite Packaging for Active Preservation of Food" (acronym BIOFOODPACK) that has been funded by the M-ERA.Net Call 2016. A crossover trial with a behavioral intervention study will be conducted. The behavioural intervention treatment consists of: i) avoiding the consumption of packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food, and ii) using the proposed bio-based packaging material to package foods ready for consumption; this bio-based packaging material (Silvex Ltd, Portugal) does not contain plasticizers, it is biodegradable and made out of plant-based materials (corn, starch, etc.). The objectives of this study are:
- To describe the body burden of plasticizers for women aged 18-40 years systematically adopting the intervention treatment package during the 5-day period.
- To assess the diurnal variability of the plasticizers, based on regular daily activities of the young adult women.
Read the detailed description
The duration of this study will be 12 days; the intervention period will last for 5-days, followed by the 2-day wash out and then another 5-day period for the conventional period (as usual) (Figure 1). During the 5-day long intervention period, all participants will be asked to: i) refrain from packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food and ii) use the bio-based food packaging material to package their food.
The participants will be randomly allocated to the treatment period or the conventional period (as usual scenario) for 5 days, each and following a washout period of 2 days, they will use the biodegradable food packaging material and no plastic packaging for their ready to eat foods for the next 5 days.
A baseline questionnaire will be used to collect information on demographic characteristics, individual habits, diet and non-dietary potential endocrine-disruptive chemicals exposures, while a diary will be used daily by participants so that they report the time for consumption of packaged food/drinks, for use of personal care products and for other activities like handwashing and use of microwave. Both the baseline questionnaire and diary will be developed online using the REDCap platform. Participants will provide us with an informed consent that they will strictly follow the protocol in both phases.
Standardized methodologies to quantify endocrine-disruptive chemicals (bisphenols, free and total) in urine samples and in packaged food using standardized protocols will be used. Urine samples will be analyzed at the Water and Health laboratory for plasticizers (bisphenols both free and total forms) using established human biomonitoring methods. The methods for the plasticizer compounds will be those used by the U.S. CDC. Standardized measurements for metabolomics and cortisol will also take place.
- Conditions
- Dietary Exposure
- Being tested
- Use of bio-plastic food packaging material and avoidance of plastic food packaging material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of bio-plastic food packaging material and avoidance of plastic food packaging materialBehavioural
The bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional phase (use of conventional food packaging material) | No intervention | During the conventional phase, participants are asked to maintain their usual habits for 5 days. |
| Intervention phase (use of bio-plastic and no plastic food packaging material) | Experimental | During the 5-day long intervention period, all participants will be asked to: i) refrain from packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food and ii) use the bio-based food packaging material to package their food. Receives: Behavioral: Use of bio-plastic food packaging material and avoidance of plastic food packaging material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary plasticizers levels during the study period
Assess if plasticizers levels such as bisphenols (free and total) differ between the intervention phase and the conventional phase. Plasticizers will be measured in spot urine samples of day 1 and 5 of each phase using GC-MS/MS methodology.
Measured: 10 days
Diurnal variability of urinary plasticizers levels during the study period
Assess the diurnal variability of plasticizers, based on regular daily activities of the young adult women that will be recorded in the diary and the plasticizers levels in the spot urine samples taken on day 1 and day 5 of each phase. Plasticizers will be measured using GC-MS/MS methodology.
Measured: 10 days
Secondary outcomes (2)
Diurnal variability of urinary cortisol levels during the study period
Assess the diurnal variability of cortisol, based on regular daily activities of the young adult women that will be recorded in the diary and the cortisol levels in the spot urine samples taken on day 1 and day 5 of each phase. Cortisol will be measured using GC-MS/MS methodology.
Measured: 10 days
Differentiated metabolite change (fold change) for metabolomics platform-based profiles in two study periods
Untargeted GC-MS metabolomics analysis
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start15 Jul 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Makris, Cyprus University of Technology
- Investigators
- Konstantinos Makris, PhD, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963842
- Sponsor's protocol ID
- BIOFOODPACK
- Acronym
- BIOFOODPACK
- Status last verified
- Sep 2022
- First submitted
- 18 Jun 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication, anonymized data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining the Effects of Avoiding the Consumption of Packaged Food and Promoting the Use of Bioplastic Food Packaging on the Body Burden of Plasticizers in Young Women: A Pilot Cross-over Study
- ClinicalTrials.gov ID
- NCT04963842
- Acronym / sponsor ID
- BIOFOODPACK / BIOFOODPACK
- Conditions
- Dietary Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A trial study was proposed as part of the project "Biocomposite Packaging for Active Preservation of Food" (acronym BIOFOODPACK) that has been funded by the M-ERA.Net Call 2016. A crossover trial with a behavioral intervention study will be conducted. The behavioural intervention treatment consists of: i) avoiding the consumption of packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food, and ii) using the proposed bio-based packaging material to package foods ready for consumption; this bio-based packaging material (Silvex Ltd, Portugal) does not contain plasticizers, it is biodegradable and made out of plant-based materials (corn, starch, etc.). The objectives of this study are:
- To describe the body burden of plasticizers for women aged 18-40 years systematically adopting the intervention treatment package during the 5-day period.
- To assess the diurnal variability of the plasticizers, based on regular daily activities of the young adult women.
Detailed description
The duration of this study will be 12 days; the intervention period will last for 5-days, followed by the 2-day wash out and then another 5-day period for the conventional period (as usual) (Figure 1). During the 5-day long intervention period, all participants will be asked to: i) refrain from packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food and ii) use the bio-based food packaging material to package their food.
The participants will be randomly allocated to the treatment period or the conventional period (as usual scenario) for 5 days, each and following a washout period of 2 days, they will use the biodegradable food packaging material and no plastic packaging for their ready to eat foods for the next 5 days.
A baseline questionnaire will be used to collect information on demographic characteristics, individual habits, diet and non-dietary potential endocrine-disruptive chemicals exposures, while a diary will be used daily by participants so that they report the time for consumption of packaged food/drinks, for use of personal care products and for other activities like handwashing and use of microwave. Both the baseline questionnaire and diary will be developed online using the REDCap platform. Participants will provide us with an informed consent that they will strictly follow the protocol in both phases.
Standardized methodologies to quantify endocrine-disruptive chemicals (bisphenols, free and total) in urine samples and in packaged food using standardized protocols will be used. Urine samples will be analyzed at the Water and Health laboratory for plasticizers (bisphenols both free and total forms) using established human biomonitoring methods. The methods for the plasticizer compounds will be those used by the U.S. CDC. Standardized measurements for metabolomics and cortisol will also take place.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional phase (use of conventional food packaging material) | No intervention | –During the conventional phase, participants are asked to maintain their usual habits for 5 days. |
| Intervention phase (use of bio-plastic and no plastic food packaging material) | Experimental | Behavioral: Use of bio-plastic food packaging material and avoidance of plastic food packaging materialDuring the 5-day long intervention period, all participants will be asked to: i) refrain from packaged (cans, plastic, paper) ready to consume foods, and foods from take away/delivery/fast food and ii) use the bio-based food packaging material to package their food. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ηealthy young women at the age of 18-40 years old, who reside in Cyprus at least the last five years. Also, subjects will be included if they routinely consume food previously packaged in plastic packaging materials/boxes
Key exclusion criteria (1 listed)
- Women with medical history, such as those taking medication for any chronic disease such as asthma, type I diabetes and those who systematically don't use or buy plastic packaged food.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of bio-plastic food packaging material and avoidance of plastic food packaging materialThe bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed. | Behavioural | Intervention phase (use of bio-plastic and no plastic food packaging material) |
Primary outcome
Urinary plasticizers levels during the study period
Time frame: 10 days
Assess if plasticizers levels such as bisphenols (free and total) differ between the intervention phase and the conventional phase. Plasticizers will be measured in spot urine samples of day 1 and 5 of each phase using GC-MS/MS methodology.
Diurnal variability of urinary plasticizers levels during the study period
Time frame: 10 days
Assess the diurnal variability of plasticizers, based on regular daily activities of the young adult women that will be recorded in the diary and the plasticizers levels in the spot urine samples taken on day 1 and day 5 of each phase. Plasticizers will be measured using GC-MS/MS methodology.
2 secondary outcomes
Diurnal variability of urinary cortisol levels during the study period
Time frame: 10 days
Differentiated metabolite change (fold change) for metabolomics platform-based profiles in two study periods
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Yes. Upon publication, anonymized data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Makris, PhD principal investigator
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of bio-plastic food packaging material and avoidance of plastic food packaging material in people with Dietary Exposure, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary plasticizers levels during the study period (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.