The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.

Stem Cells Clinical Trial

Official title:

The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219161
• Other study ID #: U0001
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stem Cells

Intervention

Dietary Supplement:
• NAD3
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)

Locations

Country	Name	City	State
United States	The University of Memphis	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Compound Solutions Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of stem cell numbers in blood circulation.	Flow cytometry evaluation of stem cell phenotype.	Changes at 1 and 2 hours after consumption of study product.
Secondary	Change to numbers of circulating HSC- CD45, CD34, CD133.	Flow cytometry evaluation of stem cell phenotype.	Changes at 1 and 2 hours after consumption of study product.
Secondary	Change to numbers of circulating CEC - CD45, CD31, CD309.	Flow cytometry evaluation of stem cell phenotype.	Changes at 1 and 2 hours after consumption of study product.
Secondary	Change to numbers of circulating MSC-CD45, CD31, CD90.	Flow cytometry evaluation of stem cell phenotype.	Changes at 1 and 2 hours after consumption of study product.