The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Daily supplementation with NMN-C at 400 mg for 29 days in total
Vitalabs Clinic
Toronto, Ontario, Canada
Safety as measured by subject incident of treatment-emergent adverse events
Subject incidence of treatment-emergent adverse events
Time frame: between Day 1 and Day 30
Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)
Time frame: between Day 1 and Day 30
Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete blood count, C reactive protein, AST, ALT, bilirubin, GGT, Alkaline phosphatase, creatinine, creatine kinase, Sodium, Potassium, Chloride)
Time frame: between Day 1 and Day 30
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Changes in body weight
Time frame: Day 1, Day 29
Tolerance
The number of participants with Adverse Events
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Changes in Quality of life
the mean changes in the the generic Quality of Life Self-Assessment Questionnaire SF-36 questionnaire score (The SF-36 questionnaire is scaled from a 0 to 100. The lower the score the more disability)
Time frame: Day 1, Day 29
Changes in Sleep quality
the mean changes in the Sleep Quality Scale (SQS) score (SQS is providing an overall score ranging from 0 to 84, where lower scores denote a healthier sleep quality)
Time frame: Day 1, Day 29
Changes in Fatigue state
the mean changes in the Multidimensional Fatigue Inventory (MFI-20) score (MFI-20 is providing an overall score ranging from 20 to 100 (a higher score indicates a higher level of fatigue).
Time frame: Day 1, Day 29
Change in blood lipid profile from baseline during the intervention period
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated
Time frame: Day 1, Day 29
Change in blood glucose (fasting) from baseline during the intervention period
the McNair Cognitive Difficulty Self Questionnaire
Time frame: Day 1, Day 29
Change from baseline in homocysteine concentrations
homocysteine level will be evaluated in plasma
Time frame: Day 1, Day 29