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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2023-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stem Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, placebo controlled, double blind, crossover study with a two-week washout period.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

NAD3

Intervention Type 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)

Placebo

500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule

Group Type PLACEBO_COMPARATOR

NAD3

Intervention Type 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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes