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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Dietary supplement: Niagen®; Other: NAD+; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JESSIE HAWKINS, PhD; Phone Number: 2562039010; Email: j.hawkins@nutraceuticalsresearch.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Nutraceuticals Research Institute
      • Contact: JESSIE HAWKINS, PhD; Phone Number: 2562039010; Email: j.hawkins@nutraceuticalsresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NR via IM injection; 100mg NR 2ml bacteriostatic water via intramuscular (IM) injection	Dietary supplement: Niagen®; nicotinamide riboside
Experimental: NR via subcutaneous injection; 100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection	Dietary supplement: Niagen®; nicotinamide riboside
Experimental: NR via IV push; 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection	Dietary supplement: Niagen®; nicotinamide riboside
Active Comparator: NAD+ via IM injection; 100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection	Other: NAD+; Nicotinamide adenine dinucleotide
Active Comparator: NAD+ via subcutaneous injection; 100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection	Other: NAD+; Nicotinamide adenine dinucleotide
Active Comparator: NAD+ via IV push; 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection	Other: NAD+; Nicotinamide adenine dinucleotide
Placebo Comparator: placebo via IM injection; 2ml bacteriostatic water via intramuscular (IM) injection	Other: Placebo; bacteriostatic water
Placebo Comparator: placebo via subcutaneous injection; 2ml bacteriostatic water via subcutaneous (SQ) injection	Other: Placebo; bacteriostatic water
Placebo Comparator: placebo via IV push; 2ml bacteriostatic water via intravenous push (IVP) injection	Other: Placebo; bacteriostatic water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 minute after injection is complete
Subjective Discomfort	Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.	1 minute after injection is complete

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	CRP in serum	baseline, 90 minutes post injection, day 10
Sed Rate	erythrocyte sedimentation rate through whole blood	baseline, 90 minutes post injection, day 10
plasma viscosity	Plasma viscosity was measured through blood plasma.	baseline, 90 minutes post injection, day 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 10
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.	Baseline, Day 10

Collaborators and Investigators

• Sponsor: Nutraceuticals Research Institute
• Collaborators: ChromaDex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: NAD+
• Other Study ID Numbers: 24-09-1300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No