Stem CellsNCT06219161
The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
A study testing NAD3 in people with Stem Cells, run by University of Memphis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cells
- What is being tested?
- NAD3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stem Cells
- Being tested
- NAD3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAD3Dietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: NAD3 |
| Placebo | Placebo comparator | 500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule Receives: Dietary Supplement: NAD3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of stem cell numbers in blood circulation.
Flow cytometry evaluation of stem cell phenotype.
Measured: Changes at 1 and 2 hours after consumption of study product.
Secondary outcomes (3)
Change to numbers of circulating HSC- CD45, CD34, CD133.
Flow cytometry evaluation of stem cell phenotype.
Measured: 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.
Measured: 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.
Measured: Changes at 1 and 2 hours after consumption of study product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start2 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo controlled, double blind, crossover study with a two-week washout period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Compound Solutions Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219161
- Sponsor's protocol ID
- U0001
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
- ClinicalTrials.gov ID
- NCT06219161
- Acronym / sponsor ID
- U0001
- Conditions
- Stem Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Compound Solutions Inc.
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, double blind, crossover study with a two-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Test product (NAD3) | Active comparator | Dietary Supplement: NAD3344 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 | Placebo comparator | Dietary Supplement: NAD3500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAD3NAD3 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) | Dietary supplement | Placebo, Test product (NAD3) |
Primary outcome
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.
3 secondary outcomes
Change to numbers of circulating HSC- CD45, CD34, CD133.
Time frame: Changes at 1 and 2 hours after consumption of study product.
Change to numbers of circulating CEC - CD45, CD31, CD309.
Time frame: Changes at 1 and 2 hours after consumption of study product.
Change to numbers of circulating MSC-CD45, CD31, CD90.
Time frame: Changes at 1 and 2 hours after consumption of study product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAD3 in people with Stem Cells, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of stem cell numbers in blood circulation. (time frame: Changes at 1 and 2 hours after consumption of study product.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.