NCT06247579

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

January 7, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

Gut microbiomeAnxietyDepressionPolystyrene microplastics

Outcome Measures

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.

    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

    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

Study Arms (2)

The control group

NO INTERVENTION

The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months.

The exposure group

EXPERIMENTAL

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

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

The exposure group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ju Gao

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The exposure group will use disposable plastic tableware (DPT) made of polystyrene, provided by the hospital canteens for two months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.; attending doctor

Study Record Dates

First Submitted

January 7, 2024

First Posted

February 8, 2024

Study Start

January 1, 2024

Primary Completion

April 25, 2024

Study Completion

May 1, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations