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Metabolic DisturbancePhase 1NCT02689882

"Pharmacokinetic Study of Nicotinamide Riboside"

A Phase 1 study testing nicotinamide riboside in people with Metabolic Disturbance, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®, ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for NR have not been reported in humans. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Disturbance
What is being tested?
nicotinamide riboside
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Nov 2015to Feb 2016
Phase
Phase 1
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 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy, adult (age 21-50 years), male or female
  • Willing and able to provide informed consent

Who cannot join

  • Current smoking
  • Receiving concurrent medications or supplements
  • History of liver, renal, cardiovascular, endocrine, or neurological disease
  • Known allergy to niacin or nicotinamide ribosome
  • Unwilling to refrain from drinking alcohol during the duration of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®, ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for NR have not been reported in humans. This study will use a recently-developed, whole blood assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily, and will collect history, physical examination and laboratory data to determine the safety and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether this NR dose significantly raises whole blood NAD levels.

Read the detailed description
  1. On Day 1, participants will have a baseline assessment, including blood pressure and heart rate, as well as baseline assessment of "safety" labs: complete blood count with white blood count differential and platelets, serum chemistry panel (sodium, potassium, chloride, glucose, blood urea nitrogen and creatinine), uric acid, creatine kinase, aspartate aminotransferase and alanine aminotransferase, and lactate dehydrogenase.
  2. Participants will receive 250 mg nicotinamide riboside (NR) by mouth daily on Days 1-2, 250 mg NR by mouth twice daily on Days 3-4, 500 mg NR twice daily by mouth on Days 5-6 and 1000 mg NR twice daily by mouth on Days 7-8.
  3. On Day 2, a blood sample will be obtained from each participant to measure serum chemistry panel to assess for the possibility of hyperkalemia and hyperglycemia. In addition, an instant read potassium will be measured using a point-of-care device available on the University of Washington (UW) General Clinical Research Center (GCRC). If the potassium is greater than 5.5, a repeat value and an ECG will be performed and the Study Investigator. If it is greater than 6.0, the Study Investigator will evaluate the subject for admission.
  4. On Day 9 prior to receiving their morning dose, participants will be admitted to the UW GCRC for an overnight stay.
  5. In the UW GCRC, the participants will receive the last 1000 mg dose of NR at time=0.
  6. Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours.
  7. Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+.
  8. "Safety labs" performed on Day 1 will be repeated
Being tested
nicotinamide riboside
Keywords
nicotinamide riboside, nicotinamide ribonucleoside, Nicotinamide-Adenine Dinucleotide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotinamide ribosideDietary supplement

    Also called Niagen

    Nicotinamide riboside dose up-titration: Days 1 and 2: 250 mg by mouth daily; Days 3 and 4: 250 mg by mouth twice daily; Days 5 and 6: 500 mg by mouth twice daily; Days 7 and 8: 1000mg by mouth twice daily; Day 9: single dose of 1000mg by mouth followed by 24 hour pharmacokinetic study.

Study groups in NCT02689882
Study groupRoleWhat they receive
pharmacokinetic studyExperimentalNicotinamide riboside dose up-titration: Days 1 and 2: 250 mg by mouth daily; Days 3 and 4: 250 mg by mouth twice daily; Days 5 and 6: 500 mg by mouth twice daily; Days 7 and 8: 1000mg by mouth twice daily; Day 9: single dose of 1000mg by mouth followed by 24 hour pharmacokinetic study.
Receives: Dietary Supplement: nicotinamide riboside

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.

    Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.

    Measured: 9 days

  2. Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.

    Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.

    Measured: 9 days

Secondary outcomes (5)

  1. Effect of nicotinamide riboside on serum potassium levels

    Comparison of group mean serum potassium levels at day 1 (baseline) vs. day 9 (while on nicotinamide riboside 1000mg twice daily). Group mean potassium levels will be compared by paired t-test, with correction for multiple comparisons.

    Measured: 9 days

  2. Effect of nicotinamide riboside on serum creatine kinase levels

    Comparison of group mean serum creatine kinase levels at day 1 (baseline) vs. day 9 (while on nicotinamide riboside 1000mg twice daily). Group mean creatine kinase levels will be compared by paired t-test, with correction for multiple comparisons.

    Measured: 9 days

  3. Effect of nicotinamide riboside on serum glucose levels

    Comparison of group mean serum glucose levels at day 1 (baseline) vs. day 9 (while on nicotinamide riboside 1000mg twice daily). Group mean glucose levels will be compared by paired t-test, with correction for multiple comparisons.

    Measured: 9 days

  4. Effect of nicotinamide riboside on serum uric acid levels

    Comparison of group mean serum uric acid levels at day 1 (baseline) vs. day 9 (while on nicotinamide riboside 1000mg twice daily). Group mean uric acid levels will be compared by paired t-test, with correction for multiple comparisons.

    Measured: 9 days

  5. Effect of nicotinamide riboside on serum alanine aminotransferase levels

    Comparison of group mean serum alanine aminotransferase levels at day 1 (baseline) vs. day 9 (while on nicotinamide riboside 1000mg twice daily). Group mean alanine aminotransferase levels will be compared by paired t-test, with correction for multiple comparisons.

    Measured: 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2015
  4. Study completionFeb 2016

Resources

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 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689882
Sponsor's protocol ID
HL126209-01S1
Other IDs
R21HL126209-01S1
Status last verified
Feb 2018
First submitted
16 Feb 2016
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Airhart SE, Shireman LM, Risler LJ, Anderson GD, Nagana Gowda GA, Raftery D, Tian R, Shen DD, O'Brien KD. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR) and its effects on blood NAD+ levels in healthy volunteers. PLoS One. 2017 Dec 6;12(12):e0186459. doi: 10.1371/journal.pone.0186459. eCollection 2017.

    PubMed 29211728

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing nicotinamide riboside in people with Metabolic Disturbance, run by University of Washington 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Feb 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. (time frame: 9 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02689882, which also lists 1 linked publication.

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 8 Feb 2018.

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