Clinical trial NCT02712593: A Study Investigating the Effects of Niagen™ in Healthy Adults.
Official title: A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bioavailability
Keywords: Healthy participants
Dietary supplement
Bioavailability
Niagen™
Nicotinamide riboside
N-methylnicotinamide
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: ChromaDex, Inc.
First posted: 2016-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Urinary Methylnicotinamide
timeFrame: 8 weeks: from baseline to end of study
Secondary outcomes:
measure: Blood Nicotinamide Riboside Metabolites
timeFrame: 8 weeks: from baseline to end of study
measure: Urinary Nicotinamide Riboside Metabolites
timeFrame: 8 weeks: from baseline to end of study
measure: Muscle Nicotinamide Riboside Metabolites
timeFrame: 8 weeks: from baseline to end of study
Other outcomes:
measure: Resting Metabolic Rate
timeFrame: 8 weeks: from baseline to end of study
measure: Expression profile: Branched Amino Acids
timeFrame: 8 weeks: from baseline to end of study
measure: Expression profile: high sensitivity C-reactive protein
timeFrame: 8 weeks: from baseline to end of study
measure: Incidence of Abnormal Vital Signs
timeFrame: 8 weeks: from baseline to end of study
measure: Incidence of Abnormal Laboratory Values
timeFrame: 8 weeks: baseline to end of study
measure: Incidence of Adverse Events
timeFrame: 8 weeks: baseline to end of study
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Gordon Schacter, MD
role: PRINCIPAL_INVESTIGATOR
References: