Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

Stress Clinical Trial

Official title:

Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381479
• Other study ID #: B031
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: National Taiwan Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

Description:

This is a double blind, randomized control study, which will be conducted by National Taiwan Sport University. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. Volunteers will be asked to fill in the Perceived Stress Scale questionnaire before recruiting. Subjects who meet the criteria will be asked to fill the different questionnaires to evaluate their stress, emotions, gastrointestinal tract symptoms, sleep status and blood draw is also needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 20 to 60 years old

• Perceived Stress Scale (PSS) score is greater than or equal to 14 points

Exclusion Criteria:

• Have used antibiotics or probiotic products in powder, capsule or tablet form within one month

• Those who are taking Chinese medicine or Western medicine to treat severe acute diseases

• Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness

• Pregnant or breastfeeding

• Those who have participated in other interventional clinical studies in the past three months

• Who has conflict of interest with PI or unsuitable to participate in the research such as students directly supervised by the project host and those who are unable to read the consent form

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders
• Stress

Intervention

Dietary Supplement:
• probiotics
each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use
• placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Locations

Country	Name	City	State
Taiwan	Graduate Institute of Sports Science, National Taiwan Sport University	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan Sport University	Bened Biomedical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol	Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase body's metabolism of glucose control blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by body to ensure the balance is correct.	From Baseline to 8 Weeks Assessed
Secondary	Perceived Stress Scale (PSS)	The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.	From Baseline to 8 Weeks Assessed
Secondary	Job Stress Scale	The job stress scale from Ministry of Labor is a rating tool used to gauge of stress.	From Baseline to 8 Weeks Assessed
Secondary	Overwork Survey	This survey is used as self-evaluation of whether an employee overworks, based on the Overwork Survey by Occupational Safety and Health Administration, Ministry of Labor. The survey includes personal-related overwork and work-related overwork.	From Baseline to 8 Weeks Assessed
Secondary	Insomnia Severity index (ISI)	The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome.The minimum total score possible is 0 and the maximum total score possible is 28. Higher values represent a worse outcome.	From Baseline to 8 Weeks Assessed
Secondary	The State Trait Anxiety Inventory (STAI)	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.	From Baseline to 8 Weeks Assessed
Secondary	Depression Anxiety Stress Scales (DASS-42)	The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress	From Baseline to 8 Weeks Assessed
Secondary	The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16	The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life. The minimum total score possible is 14 and the maximum total score possible is 70. The higher score the better satisfaction.	From Baseline to 8 Weeks Assessed
Secondary	VAS-GI	Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics.	From Baseline to 8 Weeks Assessed
Secondary	Patient Global Impression scales of Improvement rated by patient, PGI-C	The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy.	From Baseline to 8 Weeks Assessed
Secondary	Serotonin	Levels of serotonin in serum	From Baseline to 8 Weeks Assessed
Secondary	GABA	Levels of GABA in serum	From Baseline to 8 Weeks Assessed
Secondary	Norepinephrine	Levels of Norepinephrine in serum	From Baseline to 8 Weeks Assessed
Secondary	Immunoglobulin A, IgA	Levels of Immunoglobulin A, IgA in serum	From Baseline to 8 Weeks Assessed
Secondary	adrenocorticotropic hormone, ACTH	Levels of adrenocorticotropic hormone, ACTH in serum	From Baseline to 8 Weeks Assessed
Secondary	Total Antioxidant Capacity , TAC	Levels of Total Antioxidant Capacity , TAC in serum	From Baseline to 8 Weeks Assessed