Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Stress
• Intervention / Treatment: Dietary supplement: probiotics; Dietary supplement: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33301
    • Graduate Institute of Sports Science, National Taiwan Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: probiotics; Probiotic capsules	Dietary supplement: probiotics; each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use
Placebo Comparator: placebo; Placebo capsules	Dietary supplement: placebo; The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Serotonin	Levels of serotonin in serum	From Baseline to 8 Weeks Assessed
GABA	Levels of GABA in serum	From Baseline to 8 Weeks Assessed
Norepinephrine	Levels of Norepinephrine in serum	From Baseline to 8 Weeks Assessed
Immunoglobulin A, IgA	Levels of Immunoglobulin A, IgA in serum	From Baseline to 8 Weeks Assessed
adrenocorticotropic hormone, ACTH	Levels of adrenocorticotropic hormone, ACTH in serum	From Baseline to 8 Weeks Assessed
Total Antioxidant Capacity , TAC	Levels of Total Antioxidant Capacity , TAC in serum	From Baseline to 8 Weeks Assessed

Collaborators and Investigators

• Sponsor: National Taiwan Sport University
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): August 26, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: probiotics
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: B031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No