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

Bioavailability Clinical Trial

— 15NRHC  

Official title:

A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712593
• Other study ID #: 15NRHC
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2016
• Last updated: April 10, 2018
• Start date: March 21, 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2018
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• Niagen™ 100

• Niagen™ 300

• Niagen™ 1000

Other:
• Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	ChromaDex

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting Metabolic Rate	Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter	8 weeks: from baseline to end of study
Other	Expression profile: Branched Amino Acids		8 weeks: from baseline to end of study
Other	Expression profile: high sensitivity C-reactive protein		8 weeks: from baseline to end of study
Other	Incidence of Abnormal Vital Signs	Resting blood pressure	8 weeks: from baseline to end of study
Other	Incidence of Abnormal Laboratory Values	Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol	8 weeks: baseline to end of study
Other	Incidence of Adverse Events	Review of adverse events	8 weeks: baseline to end of study
Primary	Urinary Methylnicotinamide	Change in levels	8 weeks: from baseline to end of study
Secondary	Blood Nicotinamide Riboside Metabolites	Change in levels	8 weeks: from baseline to end of study
Secondary	Urinary Nicotinamide Riboside Metabolites	Change in levels	8 weeks: from baseline to end of study
Secondary	Muscle Nicotinamide Riboside Metabolites	Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy	8 weeks: from baseline to end of study