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

NCT06919328 | Recruiting

• 1 other identifier: 24-09-1300
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Aging

Keywords

NAD+

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• C-reactive protein

  baseline, 90 minutes post injection, day 10

• Sed Rate

  baseline, 90 minutes post injection, day 10

• plasma viscosity

  baseline, 90 minutes post injection, day 10

Other Outcomes (2)

• NRI Sleep Scale

  Baseline, Day 10

• NRI Energy Scale

  Baseline, Day 10

Study Arms (9)

NR via IM injection

EXPERIMENTAL

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

Dietary Supplement: Niagen®

NR via subcutaneous injection

EXPERIMENTAL

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

Dietary Supplement: Niagen®

NR via IV push

EXPERIMENTAL

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

Dietary Supplement: Niagen®

NAD+ via IM injection

ACTIVE COMPARATOR

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

Other: NAD+

NAD+ via subcutaneous injection

ACTIVE COMPARATOR

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

Other: NAD+

NAD+ via IV push

ACTIVE COMPARATOR

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

Other: NAD+

placebo via IM injection

PLACEBO COMPARATOR

2ml bacteriostatic water via intramuscular (IM) injection

Other: Placebo

placebo via subcutaneous injection

PLACEBO COMPARATOR

2ml bacteriostatic water via subcutaneous (SQ) injection

Other: Placebo

placebo via IV push

PLACEBO COMPARATOR

2ml bacteriostatic water via intravenous push (IVP) injection

Other: Placebo

Interventions

Niagen® DIETARY_SUPPLEMENT

nicotinamide riboside

NR via IM injection; NR via IV push; NR via subcutaneous injection

NAD+ OTHER

Nicotinamide adenine dinucleotide

NAD+ via IM injection; NAD+ via IV push; NAD+ via subcutaneous injection

Placebo OTHER

bacteriostatic water

placebo via IM injection; placebo via IV push; placebo via subcutaneous injection

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• ChromaDex, Inc.: collaborator

Study Sites (1)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-riboside; NAD

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

JESSIE HAWKINS, PhD

CONTACT

2562039010; j.hawkins@nutraceuticalsresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 9, 2025
• Study Start: October 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)