Healthy AgingNCT06919328
Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+
A study testing Niagen® and NAD+ in people with Healthy Aging, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
This study evaluates the subjective effects of injection administration of NR on healthy adult populations. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Niagen® and NAD+
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
- Lives within 100 miles of the NRI study site
- Any gender, aged 40-65, inclusive
- Good general health as evidenced by medical history
- BMI 25-34.9 kg/m2
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- Sedentary behavior (defined as <20 minutes per day or 100 minutes per week of moderate to vigorous exercise)
- Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
- ANY chronic illness (pre-disease state acceptable)
- Out of range phosphate levels at baseline
- BMI less than 25 or greater than or equal to 35
- Pregnancy, trying to conceive, or breastfeeding
- Known allergic reactions to any components of the intervention or related compounds, including any form of B3
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- Positive COVID-19 test within 30 days of the study period
- Recent dramatic weight changes (10% change in body weight in the last 6 months)
- Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins.
- Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nutraceuticals Research Institute
Huntsville, Alabama, 35801
JESSIE HAWKINS, PhD, 2562039010, j.hawkins@nutraceuticalsresearch.com
About this study
Official title: Absorption and Tolerability of Injectable Administration of Niagen®+, Nicotinamide Riboside Chloride, a Specialized Form of Vitamin B3, as Compared to NAD+: a Double Blinded, Randomized, Controlled Clinical Trial
This study evaluates the subjective effects of injection administration of NR on healthy adult populations.
Read the detailed description
The purpose of this work is to explore the tolerability of Niagen®, nicotinamide riboside chloride, a specialized form of vitamin B3, via intramuscular (IM), subcutaneous (SQ), and intravenous-push (IVP) administration, in comparison to NAD+, an active comparator, administered through the same routes.
- Conditions
- Healthy Aging
- Being tested
- Niagen®, NAD+, Placebo
- Keywords
- NAD+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niagen®Dietary supplement
nicotinamide riboside
NAD+Other
Nicotinamide adenine dinucleotide
PlaceboOther
bacteriostatic water
| Study group | Role | What they receive |
|---|---|---|
| NR via IM injection | Experimental | 100mg NR 2ml bacteriostatic water via intramuscular (IM) injection Receives: Dietary Supplement: Niagen® |
| NR via subcutaneous injection | Experimental | 100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection Receives: Dietary Supplement: Niagen® |
| NR via IV push | Experimental | 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection Receives: Dietary Supplement: Niagen® |
| NAD+ via IM injection | Active comparator | 100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection Receives: Other: NAD+ |
| NAD+ via subcutaneous injection | Active comparator | 100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection Receives: Other: NAD+ |
| NAD+ via IV push | Active comparator | 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection Receives: Other: NAD+ |
| placebo via IM injection | Placebo comparator | 2ml bacteriostatic water via intramuscular (IM) injection Receives: Other: Placebo |
| placebo via subcutaneous injection | Placebo comparator | 2ml bacteriostatic water via subcutaneous (SQ) injection Receives: Other: Placebo |
| placebo via IV push | Placebo comparator | 2ml bacteriostatic water via intravenous push (IVP) injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire
The MPQ contains 78 pain related terms to identify the quantity and type of pain experienced. This multi-dimensional tool has three components; sensory, cognitive, emotional. Higher scores indicate higher levels of pain.
Measured: 1 minute after injection is complete
Subjective Discomfort
Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.
Measured: 1 minute after injection is complete
Secondary outcomes (3)
C-reactive protein
CRP in serum
Measured: baseline, 90 minutes post injection, day 10
Sed Rate
erythrocyte sedimentation rate through whole blood
Measured: baseline, 90 minutes post injection, day 10
plasma viscosity
Plasma viscosity was measured through blood plasma.
Measured: baseline, 90 minutes post injection, day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start31 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ChromaDex, Inc.
- Responsible party
- Principal investigator, Jessie Hawkins, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919328
- Sponsor's protocol ID
- 24-09-1300
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Tolerability of Injectable Administration of Niagen®+, Nicotinamide Riboside Chloride, a Specialized Form of Vitamin B3, as Compared to NAD+: a Double Blinded, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06919328
- Acronym / sponsor ID
- 24-09-1300
- Conditions
- Healthy Aging
- Keywords
- NAD+
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- ChromaDex, Inc.
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Apr 2025 (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.
This study evaluates the subjective effects of injection administration of NR on healthy adult populations.
Detailed description
The purpose of this work is to explore the tolerability of Niagen®, nicotinamide riboside chloride, a specialized form of vitamin B3, via intramuscular (IM), subcutaneous (SQ), and intravenous-push (IVP) administration, in comparison to NAD+, an active comparator, administered through the same routes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| NR via IM injection | Experimental | Dietary Supplement: Niagen®100mg NR 2ml bacteriostatic water via intramuscular (IM) injection |
| NR via subcutaneous injection | Experimental | Dietary Supplement: Niagen®100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection |
| NR via IV push | Experimental | Dietary Supplement: Niagen®100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection |
| NAD+ via IM injection | Active comparator | Other: NAD+100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection |
| NAD+ via subcutaneous injection | Active comparator | Other: NAD+100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection |
| NAD+ via IV push | Active comparator | Other: NAD+100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection |
| placebo via IM injection | Placebo comparator | Other: Placebo2ml bacteriostatic water via intramuscular (IM) injection |
| placebo via subcutaneous injection | Placebo comparator | Other: Placebo2ml bacteriostatic water via subcutaneous (SQ) injection |
| placebo via IV push | Placebo comparator | Other: Placebo2ml bacteriostatic water via intravenous push (IVP) injection |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form
- Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
- Lives within 100 miles of the NRI study site
- Any gender, aged 40-65, inclusive
- Good general health as evidenced by medical history
Key exclusion criteria (10 listed)
- Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
- ANY chronic illness (pre-disease state acceptable)
- Out of range phosphate levels at baseline
- BMI less than 25 or greater than or equal to 35
- Pregnancy, trying to conceive, or breastfeeding
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 |
|---|---|---|
| Niagen®nicotinamide riboside | Dietary supplement | NR via IM injection, NR via IV push, NR via subcutaneous injection |
| NAD+Nicotinamide adenine dinucleotide | Other | NAD+ via IM injection, NAD+ via IV push, NAD+ via subcutaneous injection |
| Placebobacteriostatic water | Other | placebo via IM injection, placebo via IV push, placebo via subcutaneous injection |
Primary outcome
McGill Pain Questionnaire
Time frame: 1 minute after injection is complete
The MPQ contains 78 pain related terms to identify the quantity and type of pain experienced. This multi-dimensional tool has three components; sensory, cognitive, emotional. Higher scores indicate higher levels of pain.
Subjective Discomfort
Time frame: 1 minute after injection is complete
Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.
3 secondary outcomes
C-reactive protein
Time frame: baseline, 90 minutes post injection, day 10
Sed Rate
Time frame: baseline, 90 minutes post injection, day 10
plasma viscosity
Time frame: baseline, 90 minutes post injection, day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niagen® and NAD+ in people with Healthy Aging, run by Nutraceuticals Research Institute 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JESSIE HAWKINS, PhD (2562039010, j.hawkins@nutraceuticalsresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Questionnaire (time frame: 1 minute after injection is complete). The study lists 2 primary outcomes in all. 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 9 Apr 2025.