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

Nutraceuticals Research Institute

Status: Enrolling

Conditions: Healthy Aging

Treatments: Other: Placebo; Other: NAD+; Dietary Supplement: Niagen®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06919328

24-09-1300

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 9 patient groups, including a placebo group

NR via IM injection

Experimental group

Description:

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

Treatment:

Dietary Supplement: Niagen®

NR via subcutaneous injection

Experimental group

Description:

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

Treatment:

Dietary Supplement: Niagen®

NR via IV push

Experimental group

Description:

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

Treatment:

Dietary Supplement: Niagen®

NAD+ via IM injection

Active Comparator group

Description:

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

Treatment:

Other: NAD+

NAD+ via subcutaneous injection

Active Comparator group

Description:

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

Treatment:

Other: NAD+

NAD+ via IV push

Active Comparator group

Description:

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

Treatment:

Other: NAD+

placebo via IM injection

Placebo Comparator group

Description:

2ml bacteriostatic water via intramuscular (IM) injection

Treatment:

Other: Placebo

placebo via subcutaneous injection

Placebo Comparator group

Description:

2ml bacteriostatic water via subcutaneous (SQ) injection

Treatment:

Other: Placebo

placebo via IV push

Placebo Comparator group

Description:

2ml bacteriostatic water via intravenous push (IVP) injection

Treatment:

Other: Placebo