Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial
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
- Stem cell trafficking
研究概览
简要总结
The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.
详细描述
This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.
Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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);
- •BMI between 18.0 and 34.9 (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 (airplane mode is allowed), 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 food allergies related to ingredients in active test product or placebo.
结局指标
主要结局
Stem cell trafficking
时间窗: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Changes to the number of stem cells in the blood circulation (number of cells per mL blood). Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.
次要结局
- Mitochondrial volume per cell(Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug)
- Mitochondrial membrane potential per cell(Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug)