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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02712593
First Posted: March 18, 2016
Last Update Posted: February 17, 2017
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.
Collaborator:
ChromaDex
Information provided by (Responsible Party):
KGK Synergize Inc.
  Purpose
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.

Condition Intervention Phase
Bioavailability Dietary Supplement: Niagen™ 100 Dietary Supplement: Niagen™ 300 Dietary Supplement: Niagen™ 1000 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.

Further study details as provided by KGK Synergize Inc.:

Primary Outcome Measures:
  • Urinary Methylnicotinamide [ Time Frame: 8 weeks: from baseline to end of study ]
    Change in levels


Secondary Outcome Measures:
  • Blood Nicotinamide Riboside Metabolites [ Time Frame: 8 weeks: from baseline to end of study ]
    Change in levels

  • Urinary Nicotinamide Riboside Metabolites [ Time Frame: 8 weeks: from baseline to end of study ]
    Change in levels

  • Muscle Nicotinamide Riboside Metabolites [ Time Frame: 8 weeks: from baseline to end of study ]
    Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy


Other Outcome Measures:
  • Resting Metabolic Rate [ Time Frame: 8 weeks: from baseline to end of study ]
    Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter

  • Expression profile: Branched Amino Acids [ Time Frame: 8 weeks: from baseline to end of study ]
  • Expression profile: high sensitivity C-reactive protein [ Time Frame: 8 weeks: from baseline to end of study ]
  • Incidence of Abnormal Vital Signs [ Time Frame: 8 weeks: from baseline to end of study ]
    Resting blood pressure

  • Incidence of Abnormal Laboratory Values [ Time Frame: 8 weeks: baseline to end of study ]
    Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol

  • Incidence of Adverse Events [ Time Frame: 8 weeks: baseline to end of study ]
    Review of adverse events


Estimated Enrollment: 140
Study Start Date: March 2016
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niagen™ 100 Dietary Supplement: Niagen™ 100
Experimental: Niagen™ 300 Dietary Supplement: Niagen™ 300
Experimental: Niagen™ 1000 Dietary Supplement: Niagen™ 1000
Experimental: Placebo Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT02712593


Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Synergize Inc.
ChromaDex
Investigators
Principal Investigator: Gordon Schacter, MD KGK Synergize Inc.
  More Information

Responsible Party: KGK Synergize Inc.
ClinicalTrials.gov Identifier: NCT02712593     History of Changes
Other Study ID Numbers: 15NRHC
First Submitted: March 1, 2016
First Posted: March 18, 2016
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by KGK Synergize Inc.:
Healthy participants
Dietary supplement
Bioavailability
Niagen™
Nicotinamide riboside
N-methylnicotinamide

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents