Clinical trial NCT06219161: The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
Official title: The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cells
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Compound Solutions Inc.
First posted: 2024-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo controlled, double blind, crossover study with a two-week washout period.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of stem cell numbers in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption of study product.
Secondary outcomes:
measure: Change to numbers of circulating HSC- CD45, CD34, CD133.
timeFrame: Changes at 1 and 2 hours after consumption of study product.
measure: Change to numbers of circulating CEC - CD45, CD31, CD309.
timeFrame: Changes at 1 and 2 hours after consumption of study product.
measure: Change to numbers of circulating MSC-CD45, CD31, CD90.
timeFrame: Changes at 1 and 2 hours after consumption of study product.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The University of Memphis
state: Tennessee
Study officials:
References: