A Study Investigating the Effects of Niagen™ in Healthy Adults.

Phase 2

Completed

• Conditions: Bioavailability
• Interventions: Dietary Supplement: Niagen™ 100; Other: Placebo; Dietary Supplement: Niagen™ 300; Dietary Supplement: Niagen™ 1000

• Registration Number: NCT02712593
• Lead Sponsor: KGK Science Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Study Start: 2016-03-21
• Primary Completion: 2017-03-17
• Study Completion: 2017-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niagen™ 100	Niagen™ 100	-
Placebo	Placebo	-
Niagen™ 300	Niagen™ 300	-
Niagen™ 1000	Niagen™ 1000	-

Primary Outcome Measures

Name	Time	Method
Urinary Methylnicotinamide	8 weeks: from baseline to end of study	Change in levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada