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

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.

Study Overview

• Status: Completed
• Conditions: Stem Cells
• Intervention / Treatment: Dietary supplement: NAD3

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • The University of Memphis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test product (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	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)
Placebo Comparator: Placebo; 500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Compound Solutions Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: U0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No