A Study Investigating the Effects of Niagen™ in Healthy Adults. (15NRHC)

A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.

This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Other: Placebo; Dietary supplement: Niagen™ 100; Dietary supplement: Niagen™ 300; Dietary supplement: Niagen™ 1000

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 25-30kg/m²

• If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Non-hormonal intrauterine devices
  • Vasectomy of partner
• Healthy as determined by laboratory results, medical history, and physical exam
• Agrees to comply with study procedure
• Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).
• Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)
• Agrees to avoid taking Vitamin B3 (niacin, nicotinic acid,niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
• Has given voluntary, written, informed consent to participate in the study
• Agrees to avoid foods that contain high amounts of tryptophan and niacin and limit their ingestion of foods containing moderate amounts of tryptophan and niacin

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Alcohol use >2 standard alcoholic drinks per day
• History of alcohol or drug abuse within the past year
• Medicinal use of marijuana
• Diabetes (Type I or Type II)
• Subjects taking lipid lowering drugs
• History of renal and/or liver disease
• History of pellagra or niacin deficiency
• Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, and neurological disorders including epilepsy, and recent cerebrovascular disease
• Subjects with or who had recently experienced a traumatic injury, inflammation, infections or had undergone surgery
• Use of natural health products containing NR within 14 days prior to randomization and during the course of the study
• Unstable medical conditions as determined by the Qualified Investigator
• 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
• 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
• Participation in a clinical research trial within 30 days prior to randomization
• Allergy or sensitivity to study supplement ingredients
• Allergy or sensitivity to lidocaine
• Bleeding disorder
• Serum creatinine ≥ 130µmol/L for males and ≥ 125µmol/L for female
• 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 which may pose significant risk to the subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Other: Placebo
Experimental: Niagen™ 100	Dietary supplement: Niagen™ 100
Experimental: Niagen™ 300	Dietary supplement: Niagen™ 300
Experimental: Niagen™ 1000	Dietary supplement: Niagen™ 1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Methylnicotinamide	Change in levels	8 weeks: from baseline to end of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Nicotinamide Riboside Metabolites	Change in levels	8 weeks: from baseline to end of study
Urinary Nicotinamide Riboside Metabolites	Change in levels	8 weeks: from baseline to end of study
Muscle Nicotinamide Riboside Metabolites	Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy	8 weeks: from baseline to end of study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Metabolic Rate	Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter	8 weeks: from baseline to end of study
Expression profile: Branched Amino Acids		8 weeks: from baseline to end of study
Expression profile: high sensitivity C-reactive protein		8 weeks: from baseline to end of study
Incidence of Abnormal Vital Signs	Resting blood pressure	8 weeks: from baseline to end of study
Incidence of Abnormal Laboratory Values	Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol	8 weeks: baseline to end of study
Incidence of Adverse Events	Review of adverse events	8 weeks: baseline to end of study

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: ChromaDex, Inc.
• Investigators: Principal Investigator: Gordon Schacter, MD, KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): March 17, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Dietary supplement; Bioavailability; Healthy participants; Niagen™; Nicotinamide riboside; N-methylnicotinamide
• Other Study ID Numbers: 15NRHC