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Trial · Interventional

Status unknownNot applicableRegistry data

IV Administration of ChromaDex's Niagen® as Compared to NAD+

NCTNCT06382688 (opens ClinicalTrials.gov in a new tab)Other id23-08-0010
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Overview

Status
Status unknown
Phase
Not applicable
Enrollment
53 participants (actual)
Sponsor
Nutraceuticals Research Institute · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
13 Nov 2023
Primary completion
8 Mar 2024
Completion
31 Aug 2024 (estimated)
First posted
24 Apr 2024
Last update posted
24 Apr 2024
Conditions
Healthy Aging

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. N/A

    IV Administration of ChromaDex's Niagen® as Compared to NAD+

    NCT06382688

    13 Nov 2023 to est. 31 Aug 2024

Registry summary

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

This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV.

Interventions

  • NAD+ (nicotinamide adenine dinucleotide) IVDietary supplement
  • Niagen® (nicotinamide riboside) IVDietary supplement
  • Niagen® (nicotinamide riboside) oralDietary supplement
  • PlaceboOther

Arms4

  • Experimental

    NR (Cohorts 1&2)

    IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline

  • Active comparator

    Active Comparator (Cohorts 1&2)

    IV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline

  • Other

    Oral Comparator (Cohort 1 only)

    orally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules

  • Placebo comparator

    Placebo (Cohort 1 only)

    IV administered 500 ml of saline

Primary outcomes7

Outcomes the sponsor listed as primary.

  1. Blood Pressure

    Time frame · immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.

    Registry description

    blood pressure, systolic and diastolic, will be measured

  2. Heart rate

    Time frame · immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.

    Registry description

    heart rate will be measured

  3. Total NAD measured through dried blood spot testing

    Time frame · Blood spot data is collected at baseline, immediately after the intervention, 3 hours after the intervention, 6 hours after the intervention,on day 2, 7, and 14.

    Registry description

    NAD analysis will be developed from dried blood spots obtained by pricking a finger

  4. Glucose

    Time frame · baseline, at 3 hours, and 24 hours post administration of intervention

    Registry description

    Total glucose in blood via mg/dL

  5. Insulin Levels

    Time frame · baseline, at 3 hours, and 24 hours post administration of intervention

    Registry description

    Total insulin in blood via mcU/mL

  6. total NAD measured through blood and plasma

    Time frame · baseline, at 3 hours, and 24 hours post administration of intervention

    Registry description

    NAD analysis conducted on whole blood and plasma samples

  7. Tolerable Infusion Rate

    Time frame · through intervention completion, an average of 2 hours

    Registry description

    The total amount of time it takes patients to comfortably receive the IV

Secondary outcomes(4)

  1. Complete Blood Count

    Time frame · baseline, at 3 hours, and 24 hours post administration of intervention

    Registry description

    A complete blood count with differential will be evaluated through whole blood samples

  2. Comprehensive Metabolic Panel

    Time frame · baseline, at 3 hours, and 24 hours post administration of intervention

    Registry description

    comprehensive metabolic panel will be evaluated through whole blood samples

  3. Sleep Scale

    Time frame · Change from baseline at day 14

    Registry description

    This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep

  4. Energy Scale

    Time frame · Change from baseline at day 14

    Registry description

    This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels.

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
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 a NRI study site * Any gender, aged 40+ (For the 5th arm, only males will be evaluated.) * Good general health as evidenced by medical history * 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, cancer, or Parkinson's disease, * Pregnancy, trying to conceive, or breastfeeding * Known allergic reactions to any components of the intervention * 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. * Introducing a new investigational drug or other intervention within 30 days before the start of the study

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