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

April 23, 2024 updated by: Franklin Health Research

The Effects of IV Administration of ChromaDex's Niagen®, Nicotinamide Riboside Chloride as Compared to IV Administration of NAD+: A Randomized, Placebo Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this work is to establish and quantify the safety and efficacy of IV administration of ChromaDex's Niagen®, nicotinamide riboside chloride in comparison to currently available IV NAD+, a saline IV, and orally administered Niagen®

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Nutraceuticals Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NR (Cohorts 1&2)
IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline
Dietary supplement: Niagen® (nicotinamide riboside) IV
NR is a unique member of the vitamin B3 family. Cells can use NR to create nicotinamide adenine dinucleotide (NAD+), which is an essential molecule found in every living cell. Patients in this arm received an IV administration.
Active Comparator: Active Comparator (Cohorts 1&2)
IV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline
Dietary supplement: NAD+ (nicotinamide adenine dinucleotide) IV
NAD+ enables cells to generate cellular energy from the food that one eats
Other Names:
  • NAD+
Other: Oral Comparator (Cohort 1 only)
orally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules
Dietary supplement: Niagen® (nicotinamide riboside) oral
NR is a unique member of the vitamin B3 family. Cells can use NR to create nicotinamide adenine dinucleotide (NAD+), which is an essential molecule found in every living cell. Patients in this arm received an oral administration.
Other Names:
  • Niagen® (oral)
Placebo Comparator: Placebo (Cohort 1 only)
IV administered 500 ml of saline
Other: Placebo
These individuals received a saline IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
blood pressure, systolic and diastolic, will be measured
immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
Heart rate
Time Frame: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
heart rate will be measured
immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
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.
NAD analysis will be developed from dried blood spots obtained by pricking a finger
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.
Glucose
Time Frame: baseline, at 3 hours, and 24 hours post administration of intervention
Total glucose in blood via mg/dL
baseline, at 3 hours, and 24 hours post administration of intervention
Insulin Levels
Time Frame: baseline, at 3 hours, and 24 hours post administration of intervention
Total insulin in blood via mcU/mL
baseline, at 3 hours, and 24 hours post administration of intervention
total NAD measured through blood and plasma
Time Frame: baseline, at 3 hours, and 24 hours post administration of intervention
NAD analysis conducted on whole blood and plasma samples
baseline, at 3 hours, and 24 hours post administration of intervention
Tolerable Infusion Rate
Time Frame: through intervention completion, an average of 2 hours
The total amount of time it takes patients to comfortably receive the IV
through intervention completion, an average of 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Blood Count
Time Frame: baseline, at 3 hours, and 24 hours post administration of intervention
A complete blood count with differential will be evaluated through whole blood samples
baseline, at 3 hours, and 24 hours post administration of intervention
Comprehensive Metabolic Panel
Time Frame: baseline, at 3 hours, and 24 hours post administration of intervention
comprehensive metabolic panel will be evaluated through whole blood samples
baseline, at 3 hours, and 24 hours post administration of intervention
Sleep Scale
Time Frame: Change from baseline at day 14
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
Change from baseline at day 14
Energy Scale
Time Frame: Change from baseline at day 14
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.
Change from baseline at day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Experience
Time Frame: Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention
Patients will be asked open ended questions to describe the experience of receiving the IV or oral intake of the assigned product.
Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Franklin Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-08-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient consent does not include data sharing outside of pre-specified organizations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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