Investigation on the Benefits of Avoiding Conventional Food Packaging and Promoting Bioplastic Food Packaging
Condition: Dietary Exposure
Study type: Interventional

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.
    

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.
    

Intervention name(s): Use of bio-plastic food packaging material and avoidance of plastic food packaging material
Intervention type(s): Behavioral
Intervention description(s): The bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention