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

NCT02712593 | Completed Phase 2

• 1 other identifier: 15NRHC
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy participants; Dietary supplement; Bioavailability; Niagen™; Nicotinamide riboside; N-methylnicotinamide

Outcome Measures

Primary Outcomes (1)

• Urinary Methylnicotinamide

  Change in levels

  8 weeks: from baseline to end of study

Secondary Outcomes (3)

• Blood Nicotinamide Riboside Metabolites

  8 weeks: from baseline to end of study

• Urinary Nicotinamide Riboside Metabolites

  8 weeks: from baseline to end of study

• Muscle Nicotinamide Riboside Metabolites

  8 weeks: from baseline to end of study

Other Outcomes (6)

• Resting Metabolic Rate

  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

Study Arms (4)

Niagen™ 100

EXPERIMENTAL

Dietary Supplement: Niagen™ 100

Niagen™ 300

EXPERIMENTAL

Dietary Supplement: Niagen™ 300

Niagen™ 1000

EXPERIMENTAL

Dietary Supplement: Niagen™ 1000

Placebo

EXPERIMENTAL

Other: Placebo

Interventions

Niagen™ 100 DIETARY_SUPPLEMENT

Niagen™ 100

Niagen™ 300 DIETARY_SUPPLEMENT

Niagen™ 300

Niagen™ 1000 DIETARY_SUPPLEMENT

Niagen™ 1000

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• ChromaDex, Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Gordon Schacter, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 18, 2016
• Study Start: March 21, 2016
• Primary Completion: March 17, 2017
• Study Completion: April 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CA (1)