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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247579
• Other study ID #: Dietary
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Northern Jiangsu People's Hospital
• Contact: Ju Gao
• Phone: +8618118206088
• Email: gaoju_003[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 1, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Other:
• Dietary 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.

Locations

Country	Name	City	State
China	Ju Gao	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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