Clinical Poof-of-concept Study on Rapid Immune Modulating Effects
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Immune communication
研究概览
简要总结
Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.
详细描述
Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.
Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, a spit sample will also be taken for salivary IgA testing.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will not be informed on which intervention they receive on any given day.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Veins easy to see in one or both arms
- •Willing to comply with study procedures, including
- •Maintaining a consistent diet and lifestyle routine throughout the study;
- •Consistent habit of bland breakfast on days of clinic visits
- •Abstaining from exercising on and nutritional supplements on the morning of a 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, gum, computer/cell phone use, during clinic visits
排除标准
- •Previous major gastrointestinal surgery
- •Taking anti-inflammatory medications on a daily basis
- •Currently experiencing intense stressful events/life changes
- •Currently in intensive athletic training (such as marathon runner)
- •Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
- •An unusual sleep routine
- •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 sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-by-case basis
结局指标
主要结局
Immune communication
时间窗: 2 hours
Observation of changes in serum cytokine levels
次要结局
- Immune Surveillance and Alertness(2 hours)