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

A Randomized, Double-blind, Cross-over 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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Dietary supplement: Niagen 100mg; Dietary supplement: Niagen 300mg; Dietary supplement: Niagen 1000mg

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
t1/2 (terminal half-life)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC(0-24h)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
AUCI (AUC to infinity)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
AUC(0-24h)/AUCI	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
Maximum observed concentration (Cmax)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
Time of maximum concentration (Tmax),	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
λ (terminal disposition rate constant)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
AUCReftmax (Area under the curve to tmax)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours
Blood Safety parameters	CBC	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	electrolytes	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	glucose	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	creatinine	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	AST	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	ALT	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	GGT	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	uric acid	24 hour dosing period; pre dose and 24 hr post dose
Blood Safety parameters	bilirubin	24 hour dosing period; pre dose and 24 hr post dose
Vital Signs	Heart Rate	24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose
Vital Signs	Blood Pressure	24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: ChromaDex, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Niagen; Nicotinamide riboside
• Other Study ID Numbers: 14NBHC