Clinical Trial on Rapid Immune Modulating Effects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Immune cell surveillance
研究概览
简要总结
The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.
详细描述
Clinical trial comparing the acute immune effects of a nutraceutical blend, and a placebo. The nutraceutical blend is based on low molecular weight peptides isolated from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be consuming placebo or the active nutraceutical blend, separated by a 1-week washout period.
Baseline blood samples are taken 1 hour after participants arrive; the dose is then administered. Additional blood samples are taken 1 hour, 2 hours, and 3 hours following consumption of test product.
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 consume on a given clinic visit.
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;
- •Age 18-75 years (inclusive);
- •Veins easy to see in one or both arms (to allow for the multiple blood draws);
- •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 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 (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
- •Taking anti-inflammatory medications on a daily basis;
- •Currently experiencing intense stressful events/ life changes;
- •Currently in intensive athletic training (such as marathon runners);
- •Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
- •An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
- •Unwilling to maintain a constant intake of supplements over the duration of the study;
- •Anxiety about having blood drawn;
- •Pregnant, nursing, or trying to become pregnant;
- •Known allergies related to ingredients in active test product or placebo.
结局指标
主要结局
Immune cell surveillance
时间窗: 3 hours after consuming a test product for this study protocol
Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells
次要结局
- Immune cell activation status(3 hours after consuming a test product for this study protocol)