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Recruiting NCT06919328

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

No phase Interventional Healthy Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Niagen®, NAD+, Placebo.
Who it may be relevant to
Registry conditions: Healthy Aging. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

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.

Interventions

  • Dietary supplement Niagen®
    nicotinamide riboside
  • Other NAD+
    Nicotinamide adenine dinucleotide
  • Other Placebo
    bacteriostatic water

Primary outcome measures

  • McGill Pain Questionnaire [Time frame: 1 minute after injection is complete]
  • Subjective Discomfort [Time frame: 1 minute after injection is complete]
Secondary outcome measures (3)
  • C-reactive protein [Time frame: baseline, 90 minutes post injection, day 10]
  • Sed Rate [Time frame: baseline, 90 minutes post injection, day 10]
  • plasma viscosity [Time frame: baseline, 90 minutes post injection, day 10]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Nutraceuticals Research Institute — Huntsville

Identifiers

NCT: NCT06919328 · 24-09-1300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗