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OpenTrials
Completed

NCT Number: NCT06219161

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Memphis

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAD3

Dietary Supplement

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)

Primary outcomes

  1. Change of stem cell numbers in blood circulation.

    Time frame: Changes at 1 and 2 hours after consumption of study product.

    Flow cytometry evaluation of stem cell phenotype.

Secondary outcomes

  1. Change to numbers of circulating HSC- CD45, CD34, CD133.

    Time frame: Changes at 1 and 2 hours after consumption of study product.

    Flow cytometry evaluation of stem cell phenotype.

  2. Change to numbers of circulating CEC - CD45, CD31, CD309.

    Time frame: Changes at 1 and 2 hours after consumption of study product.

    Flow cytometry evaluation of stem cell phenotype.

  3. Change to numbers of circulating MSC-CD45, CD31, CD90.

    Time frame: Changes at 1 and 2 hours after consumption of study product.

    Flow cytometry evaluation of stem cell phenotype.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Compound Solutions Inc.

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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