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Completed

NCT Number: NCT06381479

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.

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Key information

Conditions

Stress Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan, 33301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use

Placebo

Dietary Supplement

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Primary outcomes

  1. Cortisol

    Time frame: From Baseline to 8 Weeks Assessed

    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.

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  2. Job Stress Scale

    Time frame: From Baseline to 8 Weeks Assessed

    The job stress scale from Ministry of Labor is a rating tool used to gauge of stress.

  3. Overwork Survey

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  4. Insomnia Severity index (ISI)

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  5. The State Trait Anxiety Inventory (STAI)

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  6. Depression Anxiety Stress Scales (DASS-42)

    Time frame: From Baseline to 8 Weeks Assessed

    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

  7. The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  8. VAS-GI

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  9. Patient Global Impression scales of Improvement rated by patient, PGI-C

    Time frame: From Baseline to 8 Weeks Assessed

    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.

  10. Serotonin

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of serotonin in serum

  11. GABA

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of GABA in serum

  12. Norepinephrine

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of Norepinephrine in serum

  13. Immunoglobulin A, IgA

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of Immunoglobulin A, IgA in serum

  14. adrenocorticotropic hormone, ACTH

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of adrenocorticotropic hormone, ACTH in serum

  15. Total Antioxidant Capacity , TAC

    Time frame: From Baseline to 8 Weeks Assessed

    Levels of Total Antioxidant Capacity , TAC in serum

Sponsors and collaborators

Lead sponsor

National Taiwan Sport University

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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