Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).
详细描述
The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.
At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.
At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed e-consent
- •Be between 18 and 45 years old, inclusive
- •In general good health, as determined by the investigator
- •Have a BMI of ≥18.5 and <30.0 kg/m2
- •Willing to consume the study product daily for the duration of the study and comply with the study procedures
- •Have moderate stress, as measured on the Cohen's Perceived Stress Scale, with a score between 14 and 26 (inclusive)
- •Be able to communicate well with the Investigator, to understand and comply with the study requirements and be judged suitable for the study in the opinion of the investigator
排除标准
- •Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9)
- •Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months
- •Have a known major stressful life event occurring (current or upcoming) during the study
- •Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD)
- •Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function
- •Use of oral or systemic (topical allowed) immunosuppressant drugs, antibiotics, steroids, etc. within the one month before screening
- •Consumption of probiotic supplements that contain live bacteria in the 4 weeks before the screening
- •Regular use of anti-inflammatory drugs such as aspirin or ibuprofen (>200mg/24 hours)
- •Food allergy or hypersensitivity to any component of the product
- •Heavy alcohol use or recent history (within one year) of illicit drug use
- •Participants who work night shifts
- •Participation in other clinical trials or studies in the last month
- •Desire and/or plans on changing current diet and/or exercise regime during the participation of this study
- •Participants who are pregnant or wish to become pregnant during the study
- •Participants who are lactating and/or currently breastfeeding
- •Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator
- •Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household
结局指标
主要结局
Perceived stress
时间窗: Before, during, and after TSST at visit 2 (week 8)
Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST
次要结局
- Anxiety(Before, during, and after TSST at visit 2 (week 8))
- STAI score(baseline and week 8)
- PSS score(baseline and week 8)
- Emotional insecurity(Before, during, and after TSST at visit 2 (week 8))
- Exhaustion(Before, during, and after TSST at visit 2 (week 8))