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Trial · Interventional

RecruitingNot applicableRegistry data

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

NCTNCT06919328 (opens ClinicalTrials.gov in a new tab)Other id24-09-1300
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Not applicable
Enrollment
70 participants (estimated)
Sponsor
Nutraceuticals Research Institute · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
31 Oct 2024
Primary completion
30 Apr 2025 (estimated)
Completion
30 Jun 2025 (estimated)
First posted
9 Apr 2025
Last update posted
9 Apr 2025
Conditions
Healthy Aging

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. N/A

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

    NCT06919328

    31 Oct 2024 to est. 30 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Niagen®Dietary supplement
  • NAD+Other
  • PlaceboOther

Arms9

  • Experimental

    NR via IM injection

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

  • Experimental

    NR via subcutaneous injection

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

  • Experimental

    NR via IV push

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

  • Active comparator

    NAD+ via IM injection

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

  • Active comparator

    NAD+ via subcutaneous injection

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

  • Active comparator

    NAD+ via IV push

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

  • Placebo comparator

    placebo via IM injection

    2ml bacteriostatic water via intramuscular (IM) injection

  • Placebo comparator

    placebo via subcutaneous injection

    2ml bacteriostatic water via subcutaneous (SQ) injection

  • Placebo comparator

    placebo via IV push

    2ml bacteriostatic water via intravenous push (IVP) injection

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. McGill Pain Questionnaire

    Time frame · 1 minute after injection is complete

    Registry description

    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.

  2. Subjective Discomfort

    Time frame · 1 minute after injection is complete

    Registry description

    Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection.

Secondary outcomes(3)

  1. C-reactive protein

    Time frame · baseline, 90 minutes post injection, day 10

    Registry description

    CRP in serum

  2. Sed Rate

    Time frame · baseline, 90 minutes post injection, day 10

    Registry description

    erythrocyte sedimentation rate through whole blood

  3. plasma viscosity

    Time frame · baseline, 90 minutes post injection, day 10

    Registry description

    Plasma viscosity was measured through blood plasma.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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