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RecruitingNCT06919328Updated Apr 9, 2025

Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+

An interventional study of Niagen® and NAD+ in Healthy Aging, sponsored by Nutraceuticals Research Institute. Recruiting at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Nutraceuticals Research Institute · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2025).
  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Aging

Keywords

  • NAD+
03

In context

Lead sponsor

Nutraceuticals Research Institute is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    NR via IM injection

    100mg NR 2ml bacteriostatic water via intramuscular (IM) injection

    Dietary Supplement: Niagen®

  • Experimental
    NR via subcutaneous injection

    100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection

    Dietary Supplement: Niagen®

  • Experimental
    NR via IV push

    100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection

    Dietary Supplement: Niagen®

  • Active comparator
    NAD+ via IM injection

    100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection

    Other: NAD+

  • Active comparator
    NAD+ via subcutaneous injection

    100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection

    Other: NAD+

  • Active comparator
    NAD+ via IV push

    100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection

    Other: NAD+

  • Placebo comparator
    placebo via IM injection

    2ml bacteriostatic water via intramuscular (IM) injection

    Other: Placebo

  • Placebo comparator
    placebo via subcutaneous injection

    2ml bacteriostatic water via subcutaneous (SQ) injection

    Other: Placebo

  • Placebo comparator
    placebo via IV push

    2ml bacteriostatic water via intravenous push (IVP) injection

    Other: Placebo

Interventions

  • Dietary supplementNiagen®

    nicotinamide riboside

  • OtherNAD+

    Nicotinamide adenine dinucleotide

  • OtherPlacebo

    bacteriostatic water

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 minute after injection is complete

  2. Subjective Discomfort

    Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.

    Time frame: 1 minute after injection is complete

Secondary outcomes

  1. C-reactive protein

    CRP in serum

    Time frame: baseline, 90 minutes post injection, day 10

  2. Sed Rate

    erythrocyte sedimentation rate through whole blood

    Time frame: baseline, 90 minutes post injection, day 10

  3. plasma viscosity

    Plasma viscosity was measured through blood plasma.

    Time frame: baseline, 90 minutes post injection, day 10

Other outcomes

  1. NRI Sleep Scale

    The NRI Sleep scale is a validated scale that measures 6 domains of sleep via a Likert scale. Higher scores indicated greater sleep disturbances.

    Time frame: Baseline, Day 10

  2. NRI Energy Scale

    The NRI Energy scale is a validated scale that measures 6 domains of fatigue via a Likert scale. Higher scores indicated greater fatigue.

    Time frame: Baseline, Day 10

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919328
Lead sponsor
Nutraceuticals Research Institute
Collaborators
ChromaDex, Inc.
Responsible party
Jessie Hawkins (PhD, Nutraceuticals Research Institute) — Principal investigator
First posted
Apr 9, 2025
Start date
Oct 31, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Apr 9, 2025

Study contacts

JESSIE HAWKINS, PhD
Contact
j.hawkins@nutraceuticalsresearch.com
2562039010

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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