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NCT Number: NCT06919328

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

This study evaluates the subjective effects of injection administration of NR on healthy adult populations.

Recruiting

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

Location status: Recruiting

Location contact

JESSIE HAWKINS, PhD

CONTACT

[email protected]

2562039010

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Niagen®

Dietary Supplement

nicotinamide riboside

NAD+

Other

Nicotinamide adenine dinucleotide

Placebo

Other

bacteriostatic water

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. C-reactive protein

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

    CRP in serum

  2. Sed Rate

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

    erythrocyte sedimentation rate through whole blood

  3. plasma viscosity

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

    Plasma viscosity was measured through blood plasma.

Other outcomes

  1. NRI Sleep Scale

    Time frame: Baseline, Day 10

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

  2. NRI Energy Scale

    Time frame: Baseline, Day 10

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

Study contacts

Contact information is provided by the study sponsor or research team.

JESSIE HAWKINS, PhD

CONTACT

[email protected]

2562039010

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Collaborators

  • ChromaDex, Inc.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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