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Completed

NCT Number: NCT02191462

A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects

The purpose of this study in to analyse the way in which the body processes Niagen (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the dose.

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Key information

Conditions

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Male or female age 30-55 years
  • BMI 18.5-29.9 kg/m2
  • If female, subject is not of child bearing potential, OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
  • Healthy as determined by laboratory results and medical history
  • Agrees to maintain current level of physical activity throughout the study
  • Agrees to avoid vitamins and St. John's Wort for 30 days prior to enrollment and during the study
  • Agrees to avoid nutritional yeast, whey proteins, energy drinks, dairy products, grapefruit and grapefruit juice and alcohol 7 days prior to enrollment and during study
  • Has given voluntary, written, informed consent to participate in the study

Exclusion criteria

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
  • Use of natural health products (NHPs)/dietary supplements within 7 days prior to randomization and during the course of the study.
  • Use of vitamins or St. John's Wort in the last 30 days before the study enrollment,
  • Use of natural health products containing Nicotinamide riboside within 7 days prior to randomization and during the course of the study
  • Use of nutritional yeast, whey proteins, energy drinks, grapefruit and grapefruit juice, dairy products, alcohol for 7 days prior to the study
  • Subjects who are smokers
  • Subjects with blood pressure ≥140/90
  • Use of blood pressure medications
  • Use of cholesterol lowering medications
  • Metabolic diseases or chronic diseases
  • Use of acute over the counter medication within 72 hours of test product dosing
  • Unstable medical conditions as determined by the Qualified Investigator
  • Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
  • Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) will be assessed by the Medical Investigator
  • Subjects who have planned surgery during the course of the trial
  • History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
  • History of blood/bleeding disorders
  • Blood donation in the past 2 months
  • Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
  • Participation in a clinical research trial within 30 days prior to randomization
  • Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
  • Individuals who are cognitively impaired and/or who are unable to give informed consent.
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Treatment and study plan

Niagen 100mg

Dietary Supplement

Niagen 300mg

Dietary Supplement

Niagen 1000mg

Dietary Supplement

Primary outcomes

  1. t1/2 (terminal half-life)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

Other outcomes

  1. Area under the curve (AUC(0-24h)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  2. AUCI (AUC to infinity)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  3. AUC(0-24h)/AUCI

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  4. Maximum observed concentration (Cmax)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  5. Time of maximum concentration (Tmax),

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  6. λ (terminal disposition rate constant)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  7. AUCReftmax (Area under the curve to tmax)

    Time frame: 24 hours

    24 hour dosing period; 3 dosing periods each separated by 7 day washout

  8. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    CBC

  9. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    electrolytes

  10. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    glucose

  11. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    creatinine

  12. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    AST

  13. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    ALT

  14. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    GGT

  15. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    uric acid

  16. Blood Safety parameters

    Time frame: 24 hour dosing period; pre dose and 24 hr post dose

    bilirubin

  17. Vital Signs

    Time frame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose

    Heart Rate

  18. Vital Signs

    Time frame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose

    Blood Pressure

Sponsors and collaborators

Lead sponsor

KGK Science Inc.

Industry

Collaborators

  • ChromaDex, Inc.

Registry information

Official study title

A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects

Acronym: 14NBHC

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2014
Registry last updated
Sep 9, 2014

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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