Exploring the Effects of Probiotics on Workplace Related Stress Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cortisol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 60 years old
- •Perceived Stress Scale (PSS) score is greater than or equal to 14 points
排除标准
- •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
结局指标
主要结局
Cortisol
时间窗: 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.
次要结局
- Insomnia Severity index (ISI)(From Baseline to 8 Weeks Assessed)
- Depression Anxiety Stress Scales (DASS-42)(From Baseline to 8 Weeks Assessed)
- The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16(From Baseline to 8 Weeks Assessed)
- Patient Global Impression scales of Improvement rated by patient, PGI-C(From Baseline to 8 Weeks Assessed)
- Serotonin(From Baseline to 8 Weeks Assessed)
- Immunoglobulin A, IgA(From Baseline to 8 Weeks Assessed)
- Job Stress Scale(From Baseline to 8 Weeks Assessed)
- Perceived Stress Scale (PSS)(From Baseline to 8 Weeks Assessed)
- Overwork Survey(From Baseline to 8 Weeks Assessed)
- GABA(From Baseline to 8 Weeks Assessed)
- adrenocorticotropic hormone, ACTH(From Baseline to 8 Weeks Assessed)
- Total Antioxidant Capacity , TAC(From Baseline to 8 Weeks Assessed)
- The State Trait Anxiety Inventory (STAI)(From Baseline to 8 Weeks Assessed)
- VAS-GI(From Baseline to 8 Weeks Assessed)
- Norepinephrine(From Baseline to 8 Weeks Assessed)
研究者
Chi-Chang Huang
Dean of Research and Development Office
National Taiwan Sport University