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

NCT06219161 | Completed

• 1 other identifier: U0001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

Test product (NAD3)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: NAD3

Interventions

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)

Placebo; Test product (NAD3)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Memphis: lead
• Compound Solutions Inc.: collaborator

Study Sites (1)

The University of Memphis

Memphis, Tennessee, 38152, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: January 2, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)