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

NCT ID: NCT06919328

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NR via IM injection

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

Group Type EXPERIMENTAL

Niagen®

Intervention Type DIETARY_SUPPLEMENT

nicotinamide riboside

NR via subcutaneous injection

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

Group Type EXPERIMENTAL

Niagen®

Intervention Type DIETARY_SUPPLEMENT

nicotinamide riboside

NR via IV push

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

Group Type EXPERIMENTAL

Niagen®

Intervention Type DIETARY_SUPPLEMENT

nicotinamide riboside

NAD+ via IM injection

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

Group Type ACTIVE_COMPARATOR

NAD+

Intervention Type OTHER

Nicotinamide adenine dinucleotide

NAD+ via subcutaneous injection

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

Group Type ACTIVE_COMPARATOR

NAD+

Intervention Type OTHER

Nicotinamide adenine dinucleotide

NAD+ via IV push

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

Group Type ACTIVE_COMPARATOR

NAD+

Intervention Type OTHER

Nicotinamide adenine dinucleotide

placebo via IM injection

2ml bacteriostatic water via intramuscular (IM) injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

bacteriostatic water

placebo via subcutaneous injection

2ml bacteriostatic water via subcutaneous (SQ) injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

bacteriostatic water

placebo via IV push

2ml bacteriostatic water via intravenous push (IVP) injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

bacteriostatic water

Interventions

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Niagen®

nicotinamide riboside

Intervention Type DIETARY_SUPPLEMENT

NAD+

Nicotinamide adenine dinucleotide

Intervention Type OTHER

Placebo

bacteriostatic water

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ChromaDex, Inc.

INDUSTRY

Sponsor Role collaborator

Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Jessie Hawkins

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nutraceuticals Research Institute

Huntsville, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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JESSIE HAWKINS, PhD

Role: CONTACT

2562039010

Facility Contacts

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JESSIE HAWKINS, PhD

Role: primary

2562039010

Other Identifiers

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24-09-1300

Identifier Type: -

Identifier Source: org_study_id

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