Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects (14NBHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02191462
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
ChromaDex, Inc.
Information provided by (Responsible Party):
KGK Science Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Dietary Supplement: Niagen 100mg Dietary Supplement: Niagen 300mg Dietary Supplement: Niagen 1000mg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
Study Start Date : July 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Niagen 100mg
1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules
Dietary Supplement: Niagen 100mg
Experimental: Niagen 300mg
3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules
Dietary Supplement: Niagen 300mg
Experimental: 1000mg Niagen
10 Niagen capsules (10 x 100mg capsule)
Dietary Supplement: Niagen 1000mg



Primary Outcome Measures :
  1. t1/2 (terminal half-life) [ Time Frame: 24 hours ]
    24 hour dosing period; 3 dosing periods each separated by 7 day washout


Other Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191462


Locations
Layout table for location information
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
ChromaDex, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dale Wilson, MD KGK Science Inc.

Layout table for additonal information
Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02191462     History of Changes
Other Study ID Numbers: 14NBHC
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Keywords provided by KGK Science Inc.:
Pharmacokinetics
Niagen
Nicotinamide riboside