Depression, AnxietyNCT06247579
Effects of Dietary Polystyrene Microplastics on Anxiety- and Depression-like Behaviors
A study testing Dietary polystyrene microplastics from disposable plastic tableware in people with Depression, Anxiety, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Dietary polystyrene microplastics from disposable plastic tableware
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer resident physician at the base of Northern Jiangsu Hospital, Yangzhou, China
Who cannot join
- received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling
- diagnosed with mental illness
- diagnosed with digestive system diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Depression, Anxiety
- Being tested
- Dietary polystyrene microplastics from disposable plastic tableware
- Keywords
- Gut microbiome, Anxiety, Depression, Polystyrene microplastics
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary polystyrene microplastics from disposable plastic tablewareOther
Microplastic release from the daily use of disposable plastic materials (e.g., plastic boxes) when holding hot food or drink.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dietary polystyrene microplastics from disposable plastic tableware |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jan 2024
- Primary completion25 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The exposure group will use disposable plastic tableware (DPT) made of polystyrene, provided by the hospital canteens for two months
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WenJing Zhao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247579
- Sponsor's protocol ID
- Dietary
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Polystyrene Microplastics From Disposable Plastic Tableware on Anxiety- and Depression-like Behaviors
- ClinicalTrials.gov ID
- NCT06247579
- Acronym / sponsor ID
- Dietary
- Conditions
- Depression, Anxiety
- Keywords
- Gut microbiome, Anxiety, Depression, Polystyrene microplastics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The exposure group will use disposable plastic tableware (DPT) made of polystyrene, provided by the hospital canteens for two months
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Dietary polystyrene microplastics from disposable plastic tablewareThe exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens for two months |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteer resident physician at the base of Northern Jiangsu Hospital, Yangzhou, China
Key exclusion criteria (3 listed)
- received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling
- diagnosed with mental illness
- diagnosed with digestive system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary polystyrene microplastics from disposable plastic tablewareMicroplastic release from the daily use of disposable plastic materials (e.g., plastic boxes) when holding hot food or drink. | Other | The exposure group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary polystyrene microplastics from disposable plastic tableware in people with Depression, Anxiety, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.