Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Stem cell surveillance
研究概览
简要总结
The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.
详细描述
The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.
Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.
The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.
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
- 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);
- •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 anxiolytic, hypnotic, or anti-depressant prescription medication;
- •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.
- •Prescription medication will be evaluated on a case-by-case basis.
研究组 & 干预措施
Crossover Group 1, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.
干预措施: Anthocyanin-rich berry extract (Dietary Supplement)
Crossover Group 1, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.
干预措施: Anthocyanin-rich flower/leaf extract (Dietary Supplement)
Crossover Group 1, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.
干预措施: Berry /leaf blend (Dietary Supplement)
Crossover Group 1, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.
干预措施: Placebo (Dietary Supplement)
Crossover Group 2, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.
干预措施: Anthocyanin-rich berry extract (Dietary Supplement)
Crossover Group 2, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.
干预措施: Anthocyanin-rich flower/leaf extract (Dietary Supplement)
Crossover Group 2, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.
干预措施: Berry /leaf blend (Dietary Supplement)
Crossover Group 2, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.
干预措施: Placebo (Dietary Supplement)
Crossover Group 3, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.
干预措施: Anthocyanin-rich berry extract (Dietary Supplement)
Crossover Group 3, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.
干预措施: Anthocyanin-rich flower/leaf extract (Dietary Supplement)
Crossover Group 3, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.
干预措施: Berry /leaf blend (Dietary Supplement)
Crossover Group 3, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.
干预措施: Placebo (Dietary Supplement)
Crossover Group 4, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.
干预措施: Anthocyanin-rich berry extract (Dietary Supplement)
Crossover Group 4, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.
干预措施: Anthocyanin-rich flower/leaf extract (Dietary Supplement)
Crossover Group 4, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.
干预措施: Berry /leaf blend (Dietary Supplement)
Crossover Group 4, randomized
Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Stem cell surveillance
时间窗: Baseline, 1 hour, 2 hours after consumption
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
- Serum cytokine levels(Baseline, 1 hour, 2 hours after consumption)