A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects (14NBHC)

KGK Science

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Dietary Supplement: Niagen 1000mg

Dietary Supplement: Niagen 100mg

Dietary Supplement: Niagen 300mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191462

14NBHC

Details and patient eligibility

About

The purpose of this study in to analyse the way in which the body processes Niagen (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the dose.

Enrollment

12 patients

Sex

All

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Male or female age 30-55 years
BMI 18.5-29.9 kg/m2
If female, subject is not of child bearing potential, OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
Healthy as determined by laboratory results and medical history
Agrees to maintain current level of physical activity throughout the study
Agrees to avoid vitamins and St. John's Wort for 30 days prior to enrollment and during the study
Agrees to avoid nutritional yeast, whey proteins, energy drinks, dairy products, grapefruit and grapefruit juice and alcohol 7 days prior to enrollment and during study
Has given voluntary, written, informed consent to participate in the study

Exclusion criteria

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
Use of natural health products (NHPs)/dietary supplements within 7 days prior to randomization and during the course of the study.
Use of vitamins or St. John's Wort in the last 30 days before the study enrollment,
Use of natural health products containing Nicotinamide riboside within 7 days prior to randomization and during the course of the study
Use of nutritional yeast, whey proteins, energy drinks, grapefruit and grapefruit juice, dairy products, alcohol for 7 days prior to the study
Subjects who are smokers
Subjects with blood pressure ≥140/90
Use of blood pressure medications
Use of cholesterol lowering medications
Metabolic diseases or chronic diseases
Use of acute over the counter medication within 72 hours of test product dosing
Unstable medical conditions as determined by the Qualified Investigator
Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
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
Subjects who have planned surgery during the course of the trial
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
History of blood/bleeding disorders
Blood donation in the past 2 months
Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
Participation in a clinical research trial within 30 days prior to randomization
Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
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 its measures or which may pose significant risk to the subject