NCT02191462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

July 11, 2014

Last Update Submit

September 8, 2014

Conditions

Pharmacokinetics

Keywords

PharmacokineticsNiagenNicotinamide riboside

Outcome Measures

Primary Outcomes (1)

  • t1/2 (terminal half-life)

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

    24 hours

Other Outcomes (18)

  • Area under the curve (AUC(0-24h)

    24 hours

  • AUCI (AUC to infinity)

    24 hours

  • AUC(0-24h)/AUCI

    24 hours

  • +15 more other outcomes

Study Arms (3)

Niagen 100mg

EXPERIMENTAL

1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules

Dietary Supplement: Niagen 100mg

Niagen 300mg

EXPERIMENTAL

3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules

Dietary Supplement: Niagen 300mg

1000mg Niagen

EXPERIMENTAL

10 Niagen capsules (10 x 100mg capsule)

Dietary Supplement: Niagen 1000mg

Interventions

Niagen 100mgDIETARY_SUPPLEMENT
Niagen 100mg
Niagen 300mgDIETARY_SUPPLEMENT
Niagen 300mg
Niagen 1000mgDIETARY_SUPPLEMENT
1000mg Niagen

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

  • Dale Wilson, MD

    KGK Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 16, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CA(1)