Vitalabs Clinic
Toronto, Ontario, M5S 2B7, Canada
NCT Number: NCT04910061
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5S 2B7, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily supplementation with NMN-C at 400 mg for 29 days in total
Time frame: between Day 1 and Day 30
Subject incidence of treatment-emergent adverse events
Time frame: between Day 1 and Day 30
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
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: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
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: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
NAD+ and NMN will be assessed in blood
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
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: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
MeNAM and NAM will be assessed in plasma
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
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: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
MeNAM and Me-2-PY will be assessed in urine
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
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
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
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: Day 1, Day 29
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
The number of participants with Adverse Events
Time frame: Day 1, Day 29
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
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
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
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated
Time frame: Day 1, Day 29
the McNair Cognitive Difficulty Self Questionnaire
Time frame: Day 1, Day 29
homocysteine level will be evaluated in plasma
Seneque SA
Industry
A Single-centre Trial to Investigate the Safety and Pharmacokinetics of Orally Administered Nicotinamide Mononucleotide (NMN, 400mg) Over 29 Days of Supplementation in Healthy Adults.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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