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

Not Applicable

Completed

• Conditions: Stem Cells
• Interventions: Dietary Supplement: NAD3

• Registration Number: NCT06219161
• Lead Sponsor: University of Memphis

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.

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test product (NAD3)	NAD3	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) per capsule
Placebo	NAD3	500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Memphis; 🇺🇸 Memphis, Tennessee, United States