- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06247579
Effects of Dietary Polystyrene Microplastics on Anxiety- and Depression-like Behaviors
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:
- Can dietary polystyrene microplastics induce alterations in the human gut microbiome?
- 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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225001
- Ju Gao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dietary
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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