Investigation on the Benefits of Avoiding Conventional Food Packaging and Promoting Bioplastic Food Packaging

NCT ID: NCT04963842

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-08-05

Brief 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.

Conditions

Dietary Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional phase (use of conventional food packaging material)

During the conventional phase, participants are asked to maintain their usual habits for 5 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention phase (use of bio-plastic and no plastic food packaging material)

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.

Group Type: EXPERIMENTAL

Use of bio-plastic food packaging material and avoidance of plastic food packaging material

Intervention Type: BEHAVIORAL

The bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed.

Interventions

Use of bio-plastic food packaging material and avoidance of plastic food packaging material

The bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cyprus University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Makris

Associate Professor of Environmental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Makris, PhD

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

Cyprus University of Technology

Limassol, , Cyprus

Countries

Cyprus

Other Identifiers

BIOFOODPACK

Identifier Type: -

Identifier Source: org_study_id