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

NCT ID: NCT06382688

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-08-31

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.

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®

Conditions

Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

NR (Cohorts 1&2)

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

Group Type: EXPERIMENTAL

Niagen® (nicotinamide riboside) IV

Intervention Type: 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.

Active Comparator (Cohorts 1&2)

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

Group Type: ACTIVE_COMPARATOR

NAD+ (nicotinamide adenine dinucleotide) IV

Intervention Type: DIETARY_SUPPLEMENT

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

Oral Comparator (Cohort 1 only)

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

Group Type: OTHER

Niagen® (nicotinamide riboside) oral

Intervention Type: 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.

Placebo (Cohort 1 only)

IV administered 500 ml of saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

These individuals received a saline IV

Interventions

NAD+ (nicotinamide adenine dinucleotide) IV

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

These individuals received a saline IV

Intervention Type: OTHER

Other Intervention Names

NAD+; Niagen® (oral)

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 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutraceuticals Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nutraceuticals Research Institute

Franklin, Tennessee, United States

Countries

United States

Other Identifiers

23-08-0010

Identifier Type: -

Identifier Source: org_study_id