The Efficacy of Probiotics on Immune and Stress Response and Overall Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Saliva Sample Cortisol
研究概览
简要总结
The purpose of this graduate student research study is to evaluate the efficacy of a multi-strain probiotic and investigate if sex differences influence the role of probiotics on stress and immunity biomarkers.
详细描述
Visit #1
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Participants will read and sign informed consent forms, HIPPA form, and SAHP Covid-19 screening form.
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Participants will perform a baseline oral saliva swab to test for the stress biomarker cortisol and immune markers, including Interleukin-1β (IL-1β) and Tumor Necrosis Factor (TNF).
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Swabs will be individually packaged. After opening the package, participants will place the swab under their tongue for 1-2 minutes.
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After swabbing is complete, the swab will be placed into the collection tube and capped immediately.
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Completed swabs will be placed and held in a sub negative 70° Fahrenheit freezer.
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Participants will complete a Quality-of-Life Questionnaire (10-15 minutes).
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As this study is double blinded, participants will be separated by gender (male and female) and will select a 90-day supply of placebo or probiotic sample at random. For each gender group there will be 50 samples to select from, comprised of a mix of 25 placebo and 25 probiotic bottles.
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Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the probiotic at a similar time each day (example: always take it in the morning or evening) Visit #2
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Participants will complete the same Quality-of-Life Questionnaire from visit #1
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Participants will perform a post-study oral saliva swab in the same manner as visit #1
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •18-90 years of age
- •Participants should be of good health
排除标准
- •Women who are self-reported as pregnant and/or breastfeeding
- •Those who suffer from any systemic illness, such as diabetes mellitus, HIV, cancer, or chronic kidney disease.
- •Persons who are diagnosed with clinical depression or anxiety, or other mental health diagnoses such as schizophrenia or Alzheimer's.
- •Persons who have taken any probiotic for 5 or more days in the 3 months prior to the trial
- •Persons having received antibiotics or non-steroid anti-inflammatory therapy in the last 3-month period prior to the study
- •Persons who work night shift
- •Persons who consume probiotic rich foods daily, such as yogurt, kimchi, kombucha, kefir, sauerkraut, tempeh, miso, and buttermilk
- •Anyone who is allergic to any ingredient in the probiotic or placebo
结局指标
主要结局
Saliva Sample Cortisol
时间窗: Change in cortisol uL between baseline and 90 days
Baseline and post-study oral saliva samples will be tested for the stress biomarker cortisol uL.
次要结局
- Saliva Sample IL-1(Change in Interleukin-1β (IL-1β) uL between baseline and 90 days)
- Saliva Sample Tumor Necrosis Factor(Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days)
研究者
JeJe Noval
Assistant Professor Nutrition and Dietetics
Loma Linda University