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Completed

NCT Number: NCT02689882

"Pharmacokinetic Study of Nicotinamide Riboside"

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.

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Key information

Conditions

Metabolic Disturbance

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

  • 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.
  • 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.
  • 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.
  • On Day 9 prior to receiving their morning dose, participants will be admitted to the UW GCRC for an overnight stay.
  • In the UW GCRC, the participants will receive the last 1000 mg dose of NR at time=0.
  • Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours.
  • Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+.
  • "Safety labs" performed on Day 1 will be repeated

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Nicotinamide riboside

Dietary Supplement

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.

Other names: Niagen

Primary outcomes

  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.

    Time frame: 9 days

    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.

  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.

    Time frame: 9 days

    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.

Secondary outcomes

  1. Effect of nicotinamide riboside on serum potassium levels

    Time frame: 9 days

    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.

  2. Effect of nicotinamide riboside on serum creatine kinase levels

    Time frame: 9 days

    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.

  3. Effect of nicotinamide riboside on serum glucose levels

    Time frame: 9 days

    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.

  4. Effect of nicotinamide riboside on serum uric acid levels

    Time frame: 9 days

    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.

  5. Effect of nicotinamide riboside on serum alanine aminotransferase levels

    Time frame: 9 days

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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