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

NCT06382688 | Active Not Recruiting

• 1 other identifier: 23-08-0010
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging

Keywords

nicotinamide adenine dinucleotide; nicotinamide riboside chloride; Niagen

Outcome Measures

Primary Outcomes (7)

• Blood Pressure

  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

  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

  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

  Total glucose in blood via mg/dL

  baseline, at 3 hours, and 24 hours post administration of intervention

• Insulin Levels

  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

  NAD analysis conducted on whole blood and plasma samples

  baseline, at 3 hours, and 24 hours post administration of intervention

• Tolerable Infusion Rate

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

  through intervention completion, an average of 2 hours

Secondary Outcomes (4)

• Complete Blood Count

  baseline, at 3 hours, and 24 hours post administration of intervention

• Comprehensive Metabolic Panel

  baseline, at 3 hours, and 24 hours post administration of intervention

• Sleep Scale

  Change from baseline at day 14

• Energy Scale

  Change from baseline at day 14

Other Outcomes (1)

• Subjective Experience

  Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention

Study Arms (4)

NR (Cohorts 1&2)

EXPERIMENTAL

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

Dietary Supplement: Niagen® (nicotinamide riboside) IV

Active Comparator (Cohorts 1&2)

ACTIVE COMPARATOR

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

Dietary Supplement: NAD+ (nicotinamide adenine dinucleotide) IV

Oral Comparator (Cohort 1 only)

OTHER

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

Dietary Supplement: Niagen® (nicotinamide riboside) oral

Placebo (Cohort 1 only)

PLACEBO COMPARATOR

IV administered 500 ml of saline

Other: Placebo

Interventions

NAD+ (nicotinamide adenine dinucleotide) IV DIETARY_SUPPLEMENT

NAD+ enables cells to generate cellular energy from the food that one eats

Also known as: NAD+

Active Comparator (Cohorts 1&2)

Niagen® (nicotinamide riboside) IV DIETARY_SUPPLEMENT

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.

NR (Cohorts 1&2)

Niagen® (nicotinamide riboside) oral DIETARY_SUPPLEMENT

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.

Also known as: Niagen® (oral)

Oral Comparator (Cohort 1 only)

Placebo OTHER

These individuals received a saline IV

Placebo (Cohort 1 only)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Nutraceuticals Research Institute

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Interventions

NAD; nicotinamide-beta-riboside

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 24, 2024
• Study Start: November 13, 2023
• Primary Completion: March 8, 2024
• Study Completion: August 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)