EpiCor Clinical Study on Rapid Immune Modulating Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Immune Surveillance
研究概览
简要总结
Clinical verification study evaluating the effects of a nutraceutical product. This study involves thirty participants composed of healthy adults, who will be taking either a placebo or nutraceutical supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the nutraceutical on immune function compared to a placebo.
详细描述
Clinical study comparing the acute immune effect of a nutraceutical product and a placebo. The nutraceutical supplement is a postbiotic whole food fermentate produced using yeast.
30 subjects will participate in a placebo-controlled, double-blind, randomized, cross-over design, wherein they will be taking a placebo, or nutraceutical product, each separated by a 1-week washout period to evaluate effects within 3 hours of consumption.
Blood samples will be taken 1 hour after participants arrive, then the dose is administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, and cytokine profiles. Ex vivo immune challenges will be used to determine the direct impacts on immune cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of any gender
- •BMI between 18 and 30 (inclusive)
- •Veins easy to see in one or both arms (to allow for multiple blood draws)
- •Willing to comply with a 24-h wash-out period for vitamins and nutritional supplements
- •Willing to comply with study procedures including: maintaining a consistent diet and lifestyle routine throughout the study; consistent habit of bland breakfasts on days of clinic visits; abstaining from exercising and nutritional supplements on the morning of the study visit; abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; abstaining from music, candy, bum, computer/cell phone use, during clinic visits.
排除标准
- •Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
- •Currently in intensive athletic training (such as marathon runners)
- •Currently taking antidepressant or tranquilizing medications
- •Taking anti-inflammatory medications on a daily basis
- •Currently experiencing intense stressful events/life changes that could negatively affect compliance
- •Anything that the investigator judges may put the subject at risk or may unduly influence any of the results of the study
- •An unusual sleep routine (examples: working nightshift, irregular routine with frequent late nights)
- •Unwilling to maintain a constant intake of supplements over the duration of the study
- •Anxiety about having blood drawn
- •People of childbearing potential: pregnant, nursing, or trying to become pregnant
- •Known food allergies related to ingredients in active test product or placebo
- •Prescription medication will be evaluated on case-by-case basis.
结局指标
主要结局
Immune Surveillance
时间窗: At 1, 2, and 3 hours
Observation of changes in immune cell trafficking and status of immune cell alertness, i.e., the changes in immune cell populations and activation following administration
次要结局
- Immune Communication(At 1, 2, and 3 hours)