The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
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 of stem cell numbers in blood circulation.
研究概览
简要总结
The goal of the study is to determine the acute and short-term supplementation effect of a commercially available theacrine-containing supplement (NAD3) on numbers of various circulating stem cell populations in older adults.
详细描述
This is a double-blind, placebo-controlled crossover study with 12 participants randomized to receive either NAD3® or a placebo for seven days. Blood samples are collected after an overnight fast, before and after the seven-day supplementation period, as well as one and two hours after the final supplement/placebo dose. Using flow cytometry, circulating stem cells, including lymphocytoid CD34+ stem cells (CD45dimCD34+), stem cells associated with vascular maintenance and repair (CD45dimCD34+CD309+), CD34+ stem cells linked to a progenitor phenotype (CD45dimCD34+CD309neg), circulating endothelial stem cells (CD45negCD31+CD309+), and mesenchymal stem cells (CD45negCD90+) are quantified.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Age 40-70
- •BMI between 21-34.99 kg/m2
- •Vital signs with in normal range (heart rate 60-100 beats/minute, blood pressure (40-44 years - 125/83, 45-49 years- 127/84, 50-54 years -129/85, 55-59 years - 131/86, >60 - 134/87), 36.4-37.4 degrees Celsius
- •Sedentary to lightly active (2 or fewer days per week of exercise)
排除标准
- •Female participants who are lactating, pregnant or planning to become pregnant during the study
- •History of use of illicit drugs or other substances of abuse within 12 months of the screening visit (to be determined at screening)
- •Tobacco during the 90 days prior to screening
- •Current use of medication/dietary supplements that claim to or have an effect on age-related processes, e.g. "anti-aging" supplements. Participants must undergo a ≥7-day washout period of no supplementation to be eligible.
- •Known allergy, intolerance or hypersensitivity to NAD3
- •Self-reported active infection or illness of any kind
- •Cognitively impaired and/or unable to give informed consent
结局指标
主要结局
Change of stem cell numbers in blood circulation.
时间窗: Changes at 1 and 2 hours after consumption of study product.
Flow cytometry evaluation of stem cell phenotype.
次要结局
- Change to numbers of circulating HSC- CD45, CD34, CD133.(Changes at 1 and 2 hours after consumption of study product.)
- Change to numbers of circulating CEC - CD45, CD31, CD309.(Changes at 1 and 2 hours after consumption of study product.)
- Change to numbers of circulating MSC-CD45, CD31, CD90.(Changes at 1 and 2 hours after consumption of study product.)