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CompletedNCT06247579Updated Aug 22, 2024

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

An interventional study of Dietary polystyrene microplastics from disposable plastic tableware in Depression, Anxiety, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
20 Years to 30 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Depression, Anxiety

Keywords

  • Gut microbiome
  • Anxiety
  • Depression
  • Polystyrene microplastics
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 15 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling
  • diagnosed with mental illness
  • diagnosed with digestive system diseases
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

    Other: Dietary polystyrene microplastics from disposable plastic tableware

Interventions

  • OtherDietary polystyrene microplastics from disposable plastic tableware

    Microplastic release from the daily use of disposable plastic materials (e.g., plastic boxes) when holding hot food or drink.

06

What researchers measure

Primary outcomes

  1. Assessing mental status using the depression anxiety stress scales-21 (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.

    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.

Secondary outcomes

  1. Alterations in human gut microbial diversity investigated through 16S rRNA

    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.

    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

07

Study locations

1 site
  • Ju Gao
    Yangzhou, Jiangsu 225001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06247579
Lead sponsor
Northern Jiangsu People's Hospital
Responsible party
WenJing Zhao (M.D.; attending doctor, Northern Jiangsu People's Hospital) — Principal investigator
First posted
Feb 8, 2024
Start date
Jan 1, 2024
Primary completion
Apr 25, 2024
Completion
May 1, 2024
Last update
Aug 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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