Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change to natural killer cell numbers in blood circulation
研究概览
简要总结
A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.
详细描述
A randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws are performed at 1 and 2 hours after consumption.
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
- None
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 both arms (to allow for the multiple blood draws);
- •Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
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;
- •Actively depressed;
- •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;
- •Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
- •Known food allergies related to ingredients in active test product.
结局指标
主要结局
Change to natural killer cell numbers in blood circulation
时间窗: Changes at 1 and 2 hours after consumption
Flow cytometry evaluation of natural killer cell numbers
次要结局
- Change to natural killer cell activation status(Changes at 1 and 2 hours after consumption)