Healthy AgingNCT06382688
IV Administration of ChromaDex's Niagen® as Compared to NAD+
A study testing NAD+ (nicotinamide adenine dinucleotide) IV, Niagen® (nicotinamide riboside) IV and Niagen® (nicotinamide riboside) oral in people with Healthy Aging, run by Nutraceuticals Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- NAD+ (nicotinamide adenine dinucleotide) IV, Niagen® (nicotinamide riboside) IV and Niagen® (nicotinamide riboside) oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutraceuticals Research Institute
Franklin, Tennessee, 37067
About this study
Official title: 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.
Read the 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
- Being tested
- NAD+ (nicotinamide adenine dinucleotide) IV, Niagen® (nicotinamide riboside) IV, Niagen® (nicotinamide riboside) oral, Placebo
- Keywords
- nicotinamide adenine dinucleotide, nicotinamide riboside chloride, Niagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAD+ (nicotinamide adenine dinucleotide) IVDietary supplement
Also called NAD+
NAD+ enables cells to generate cellular energy from the food that one eats
Niagen® (nicotinamide riboside) IVDietary 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.
Niagen® (nicotinamide riboside) oralDietary supplement
Also called Niagen® (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.
PlaceboOther
These individuals received a saline IV
| Study group | Role | What they receive |
|---|---|---|
| NR (Cohorts 1&2) | Experimental | IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline Receives: 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 Receives: 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 Receives: Dietary Supplement: Niagen® (nicotinamide riboside) oral |
| Placebo (Cohort 1 only) | Placebo comparator | IV administered 500 ml of saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
blood pressure, systolic and diastolic, will be measured
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
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
Measured: 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
Measured: baseline, at 3 hours, and 24 hours post administration of intervention
Insulin Levels
Total insulin in blood via mcU/mL
Measured: 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
Measured: 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
Measured: through intervention completion, an average of 2 hours
Secondary outcomes (4)
Complete Blood Count
A complete blood count with differential will be evaluated through whole blood samples
Measured: baseline, at 3 hours, and 24 hours post administration of intervention
Comprehensive Metabolic Panel
comprehensive metabolic panel will be evaluated through whole blood samples
Measured: baseline, at 3 hours, and 24 hours post administration of intervention
Sleep Scale
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
Measured: Change from baseline at day 14
Energy Scale
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.
Measured: Change from baseline at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start13 Nov 2023
- Primary completion8 Mar 2024
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382688
- Sponsor's protocol ID
- 23-08-0010
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient consent does not include data sharing outside of pre-specified organizations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06382688
- Acronym / sponsor ID
- 23-08-0010
- Conditions
- Healthy Aging
- Keywords
- nicotinamide adenine dinucleotide, nicotinamide riboside chloride, Niagen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NR (Cohorts 1&2) | Experimental | Dietary Supplement: Niagen® (nicotinamide riboside) IVIV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline |
| Active Comparator (Cohorts 1&2) | Active comparator | Dietary Supplement: NAD+ (nicotinamide adenine dinucleotide) IVIV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline |
| Oral Comparator (Cohort 1 only) | Other | Dietary Supplement: Niagen® (nicotinamide riboside) oralorally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules |
| Placebo (Cohort 1 only) | Placebo comparator | Other: PlaceboIV administered 500 ml of saline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAD+ (nicotinamide adenine dinucleotide) IVAlso: NAD+NAD+ enables cells to generate cellular energy from the food that one eats | Dietary supplement | Active Comparator (Cohorts 1&2) |
| Niagen® (nicotinamide riboside) IVNR 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. | Dietary supplement | NR (Cohorts 1&2) |
| Niagen® (nicotinamide riboside) oralAlso: Niagen® (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. | Dietary supplement | Oral Comparator (Cohort 1 only) |
| PlaceboThese individuals received a saline IV | Other | Placebo (Cohort 1 only) |
Primary outcome
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
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
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
Glucose
Time frame: baseline, at 3 hours, and 24 hours post administration of intervention
Total glucose in blood via mg/dL
Insulin Levels
Time frame: baseline, at 3 hours, and 24 hours post administration of intervention
Total insulin in blood via mcU/mL
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
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
4 secondary outcomes
Complete Blood Count
Time frame: 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
Sleep Scale
Time frame: Change from baseline at day 14
Energy Scale
Time frame: Change from baseline at day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No. Patient consent does not include data sharing outside of pre-specified organizations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAD+ (nicotinamide adenine dinucleotide) IV, Niagen® (nicotinamide riboside) IV and Niagen® (nicotinamide riboside) oral in people with Healthy Aging, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.