Effects of Dietary Polystyrene Microplastics on Anxiety- and Depression-like Behaviors

August 21, 2024 updated by: WenJing Zhao, Northern Jiangsu People's Hospital

Effects of Dietary Polystyrene Microplastics From Disposable Plastic Tableware on Anxiety- and Depression-like Behaviors

The objective of this clinical trial is to explore the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians. Specifically, the study aims to address two key questions:

  1. Can dietary polystyrene microplastics induce alterations in the human gut microbiome?
  2. Can dietary polystyrene microplastics exacerbate anxiety- and depression-like behaviors?

Participants will be divided into two groups based on their habitual eating practices: The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months. In contrast, the exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens, over the same period.

Study Overview

Detailed Description

The mental health and well-being of resident physicians is a critical topic that has gained increasing attention recently. Recent studies have shown a growing prevalence of mental health illnesses worldwide. For medical trainees and resident physicians, high rates of depression, anxiety, suicidal ideation, and burnout have been consistently observed. Moreover, contemporary research suggests that dietary exposure plays a pivotal role in the development of mental illnesses. Disposable plastic tableware, commonly used during resident training programs, could be a contributing factor. However, the specific effects of dietary exposure from such tableware on mental health, particularly through the gut-brain axis, remain largely unexplored. Consequently, investigating the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians is essential.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Ju Gao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteer resident physician at the base of Northern Jiangsu Hospital, Yangzhou, China

Exclusion Criteria:

  • received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling
  • diagnosed with mental illness
  • diagnosed with digestive system diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group
The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months.
Experimental: The exposure group
The exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens for two months
Microplastic release from the daily use of disposable plastic materials (e.g., plastic boxes) when holding hot food or drink.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing mental status using the depression anxiety stress scales-21 (DASS-21) questionnaire
Time Frame: At the baseline and end of this clinical trial an average of two months. the enrolled participants will be asked to complete the DASS-21 questionnaire.
In this study, the researchers utilized the Chinese version of the Depression Anxiety Stress Scales-21 (DASS-21), a widely recognized and reliable instrument for assessing depression, anxiety, and stress. This comprehensive tool is divided into three sections, each dedicated to evaluating the levels of depression, anxiety, and stress, respectively. The depression scale scores range from 0 to 21, with normal scores falling below 4. Anxiety scores also range from 0 to 21, with normal scores below 3. For stress, scores range from 0 to 18, with scores below 7 considered normal. Higher scores on any of these scales indicate elevated levels of depression, anxiety, or stress. In this research, the DASS-21 was employed to monitor the variations in anxiety and depression-like behaviors among the two groups, both at baseline and after the treatment period.
At the baseline and end of this clinical trial an average of two months. the enrolled participants will be asked to complete the DASS-21 questionnaire.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations in human gut microbial diversity investigated through 16S rRNA
Time Frame: At the beginning and conclusion of this clinical trial, spanning an average duration of two months, the enrolled participants will be asked to provide fecal samples
The gut microbiota encompasses the microorganisms residing in the human gastrointestinal tract. Microbial diversity refers to the variety of different species present in the gut microbiome. In this study, DNA extraction from fecal samples is carried out in two primary steps. Initially, the sample undergoes purification using multiple reagents and centrifugation. This process isolates the microbes by removing other fecal components. The next step involves lysing bacterial cells; this is achieved by incubating the samples in lysis buffer with agitation. Subsequently, the extracted DNA is amplified through techniques such as multiple displacement amplification. A 16S rRNA primer is then selected for gene sequencing. The sequences obtained from the 16S rRNA will be analyzed to ascertain the gut microbial diversity at the species level.
At the beginning and conclusion of this clinical trial, spanning an average duration of two months, the enrolled participants will be asked to provide fecal samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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