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

NCT ID: NCT02712593

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2017-04-30

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.

Conditions

Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Niagen™ 100

Group Type: EXPERIMENTAL

Niagen™ 100

Intervention Type: DIETARY_SUPPLEMENT

Niagen™ 300

Group Type: EXPERIMENTAL

Niagen™ 300

Intervention Type: DIETARY_SUPPLEMENT

Niagen™ 1000

Group Type: EXPERIMENTAL

Niagen™ 1000

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Interventions

Niagen™ 100

Intervention Type: DIETARY_SUPPLEMENT

Niagen™ 300

Intervention Type: DIETARY_SUPPLEMENT

Niagen™ 1000

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ChromaDex, Inc.

INDUSTRY

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordon Schacter, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

15NRHC

Identifier Type: -

Identifier Source: org_study_id