Recruiting
Phase 1

Niagen®Plus

Sponsor:

ChromaDex, Inc.

Code:

NCT07251608

Conditions

Healthy Volunteer

Fatigue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Niagen®Plus

Study Details

Brief summary:

The goal of this study is to learn about the safety of Niagen®Plus, an injectable form of nicotinamide riboside (NR), and to see how it affects levels of NAD+ in the blood. Niagen®Plus will be given either by subcutaneous (under the skin) or intramuscular (into the muscle) injection at two dose levels (50 mg or 100 mg).

The main questions this study aims to answer are:

Is Niagen®Plus safe and well-tolerated when given by injection several times over 100 days?

How do NAD+ levels in blood change after repeated doses of Niagen®Plus?

What are participants' and clinicians' experiences with the injections?

Researchers will also look at changes in fatigue, sleep, quality of life, inflammation markers, mitochondrial efficiency, and perceived skin appearance.

Participants will:

Receive three injections in clinic on Days 1-3, followed by a Day 10 follow-up visit

Self-inject Niagen®Plus at home three times per week from Days 10-100

Return to the clinic on Days 40 and 100 for safety and laboratory testing

Complete short surveys about fatigue, sleep, and overall well-being throughout the study

The study will include 40 generally healthy adults and will last about 100 days per participant.

Conditions

Healthy Volunteer

Fatigue

Study ID

NCT07251608

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Feb 15, 2026

Anticipated

Primary completion date

Feb 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Generally healthy adults, aged 18+
  • Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP).
  • NAD+ or NAD+ precursor injection naïve (including intravenous, intramuscular, subcutaneous, or other injection route) (i.e., 8 weeks abstinent)
  • Non-anemic
  • Willingness to adhere to lifestyle considerations and study procedures.
  • Ability to read English, and provide written informed consent.
  • Willingness to self-administer the study material, via subcutaneous injection for 90 days (days 10-100 of the study), and complete finger prick blood collections.

Exclusion Criteria:

  • One or more uncontrolled chronic illness including but not limited to diabetes, cardiovascular disease, liver, disease, kidney disease, or any form of cancer. An uncontrolled chronic illness, in this case, is defined as any changes to medication or other treatment modalities in the last 90 Days.
  • More than one chronic disease diagnosis under active treatment.
  • Any chronic disease, as determined by the primary investigator, that increases risk or confounds safety.
  • Any acute illness within 14 Days prior to Visit 1 (Day 1).
  • Cancer diagnosis within the last 5 years
  • Anemia (as defined by hemoglobin levels below 100 g/L, and other blood measures)
  • Current pregnancy or lactation; unwilling to use effective contraception if of childbearing potential.
  • Use of any NAD+ supplement, NAD+ precursor, or vitamin B3 product, orally, nasally, by patch, or injection within the last 60 Days. NAD+ precursors and related compounds include niacin (NA), nicotinamide (NAM), nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), NAD+, NADH, NAD+3, inositol hexanicotinate, apigenin; etc. The exception is the use of a daily oral multivitamin, that may contain vitamin B3 (niacin/nicotinamide). Such use will need to be documented.
  • Hypersensitivity or allergy to NR, niacin, other forms of vitamin B3/NAD+ precursors, bacteriostatic water
  • Significant aversion to needles or finger pricks.
  • Participation in another clinical intervention study, 90 Days (or 5 half-lives of the intervention, whichever is longer) prior to Visit 1 (Day 1).
  • Any other condition rendering the participant unsuitable per investigator.
  • Excessive daily use of alcohol, defined as 4 or more drinks on one occasion, or illicit drug use which would prevent adherence to the protocol as determined by the investigator.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 50 mg Subcutaneous Niagen®Plus

Participants receive 50 mg Niagen®Plus administered subcutaneously (under the skin) once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.

experimental: 100 mg Subcutaneous Niagen®Plus

Participants receive 100 mg Niagen®Plus administered subcutaneously once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.

experimental: 50 mg Intramuscular Niagen®Plus

Participants receive 50 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.

experimental: 100 mg Intramuscular Niagen®Plus

Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.

Interventions

Niagen®Plus

Pharmaceutical-grade nicotinamide riboside chloride (NRCl), compounded for sterility and reconstituted in bacteriostatic water for injection. Administered by subcutaneous or intramuscular injection at 50 mg or 100 mg per dose. Participants receive three clinician-administered injections during clinic visits on Days 1-3, followed by at-home subcutaneous self-administration three times per week (Monday, Wednesday, Friday) from Days 10-100, depending on study arm.

Primary outcome measure

  • Incidence and severity of adverse events [ Time Frame: From Day 1 (first injection) through Day 100 (final visit) ]
  • Blood Pressure [ Time Frame: Immediately before the first intervention, and through the 100th day of the study. ]
  • Heart Rate [ Time Frame: Immediately before the intervention and through the 100th day of the study (final visit). ]
  • Pulse Rate [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • Respiratory Rate [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • Blood Oxygen [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • Complete Blood Count [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • Comprehensive Metabolic Panel [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • Homocysteine [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]
  • High-Sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: Immediately before and through the 100th day of the study (final visit). ]

Central Contacts and Locations

Central contacts

Anne Russ, M.S.

13058482347research@impacthealthteam.com

Locations

BTT Medical Institute Aventura North

Recruiting

Miami, Florida, United States, 33180

Contacts

Robert Mogel

+1 (609) 915-9639rmogel@bttcorp.com

Karolline Catoira

7867071444research@impacthealthteam.com

Principal Investigator:

Halland Chen, M.D.

More Information

Sponsor

ChromaDex, Inc.

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ChromaDex, Inc. on 2025-11-26.