Evaluation of Plant-based Nutritional Products on Stem Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change to stem cell numbers in blood circulation.
研究概览
简要总结
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.
详细描述
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.
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, Outcomes Assessor)
盲法说明
Both the study participants and the research staff interacting with study participants will be blinded to the plant based extract versus placebo.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 20-75 years of age;
- •Body weight higher than 110 pounds;
- •BMI below 35;
排除标准
- •Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
- •Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
- •Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
- •Currently experiencing intense stressful events and life changes;
- •Actively depressed;
- •Experiencing sleep disturbances;
- •Working night shift;
- •Pregnant, nursing, or trying to become pregnant;
- •Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing;
- •Food allergies related to ingredients in test product.
研究组 & 干预措施
Berry extract I
Plant-based antioxidant-rich berry-based extract.
干预措施: Berry extract I (Other)
Berry extract II
Plant-based antioxidant-rich berry-based extract.
干预措施: Berry Extract II (Other)
Berry extract blend
Blend of plant-based antioxidant-rich berry-based extracts.
干预措施: Berry extract blend (Other)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change to stem cell numbers in blood circulation.
时间窗: Changes at 1 and 2 hours after consumption.
Flow cytometry evaluation of stem cell phenotype.
次要结局
- Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation.(Changes at 1 and 2 hours after consumption.)
- Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation.(Changes at 1 and 2 hours after consumption.)
- Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation.(Changes at 1 and 2 hours after consumption.)
- Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation.(Changes at 1 and 2 hours after consumption.)
- Change to numbers of circulating CD45- CD90+ stem cells in blood circulation.(Changes at 1 and 2 hours after consumption.)