Stem Cells
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNAD3
NAD3 supplement (per capsule): 344 mg microcrystalline cellulose,156 mg of a proprietary blend of Wasabia japonica (freeze-dried rhizome) cultivar, standardized to NLT 12,000 ppm isothiocyanates, 97.0% Theacrine, Copper Nicotinic Acid chelated complex (17-20% Copper by ICP-Mass spectroscopy)
Sponsors
Compound Solutions Inc.
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, placebo controlled, double blind, crossover study with a two-week washout period.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of stem cell numbers in blood circulation. | Changes at 1 and 2 hours after consumption of study product. | Flow cytometry evaluation of stem cell phenotype. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change to numbers of circulating HSC- CD45, CD34, CD133. | Changes at 1 and 2 hours after consumption of study product. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating CEC - CD45, CD31, CD309. | Changes at 1 and 2 hours after consumption of study product. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating MSC-CD45, CD31, CD90. | Changes at 1 and 2 hours after consumption of study product. | Flow cytometry evaluation of stem cell phenotype. |
Countries
United States
Outcome results
None listed