Sleep Disorder, Stress
Conditions
Keywords
probiotics
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTprobiotics
each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use
DIETARY_SUPPLEMENTplacebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Sponsors
Bened Biomedical Co., Ltd.
National Taiwan Sport University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol | 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
| Measure | Time frame | Description |
|---|---|---|
| Job Stress Scale | From Baseline to 8 Weeks Assessed | The job stress scale from Ministry of Labor is a rating tool used to gauge of stress. |
| Overwork Survey | 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. |
| Insomnia Severity index (ISI) | 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. |
| The State Trait Anxiety Inventory (STAI) | 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. |
| Depression Anxiety Stress Scales (DASS-42) | 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 |
| The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 | 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. |
| VAS-GI | 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. |
| Perceived Stress Scale (PSS) | 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. |
| Serotonin | From Baseline to 8 Weeks Assessed | Levels of serotonin in serum |
| GABA | From Baseline to 8 Weeks Assessed | Levels of GABA in serum |
| Norepinephrine | From Baseline to 8 Weeks Assessed | Levels of Norepinephrine in serum |
| Immunoglobulin A, IgA | From Baseline to 8 Weeks Assessed | Levels of Immunoglobulin A, IgA in serum |
| adrenocorticotropic hormone, ACTH | From Baseline to 8 Weeks Assessed | Levels of adrenocorticotropic hormone, ACTH in serum |
| Total Antioxidant Capacity , TAC | From Baseline to 8 Weeks Assessed | Levels of Total Antioxidant Capacity , TAC in serum |
| Patient Global Impression scales of Improvement rated by patient, PGI-C | 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. |
Countries
Taiwan
Outcome results
None listed