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

NCT04963842 | Completed DMC

• 1 other identifier: BIOFOODPACK
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess the diurnal variability of the plasticizers, based on regular daily activities of the young adult women.

Conditions

Dietary Exposure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 days

Secondary Outcomes (2)

• Diurnal variability of urinary cortisol levels during the study period

  10 days

• Differentiated metabolite change (fold change) for metabolomics platform-based profiles in two study periods

  10 days

Study Arms (2)

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Cyprus University of Technology

Limassol, Cyprus

Location

Study Officials

• Konstantinos Makris, PhD

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Environmental Health

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 15, 2021
• Study Start: July 15, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon publication
• Access Criteria: Open Access

Locations

CY (1)