Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04963842 |
Other study ID # |
BIOFOODPACK |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 15, 2021 |
Est. completion date |
August 5, 2022 |
Study information
Verified date |
September 2022 |
Source |
Cyprus University of Technology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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:
1. To describe the body burden of plasticizers for women aged 18-40 years systematically
adopting the intervention treatment package during the 5-day period.
2. To assess the diurnal variability of the plasticizers, based on regular daily activities
of the young adult women.
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.