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Completed

NCT Number: NCT04910061

Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitalabs Clinic

Toronto, Ontario, M5S 2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
  • Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
  • BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
  • Having given written informed consent to participate in the research trial.
  • Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)

Exclusion criteria

  • Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
  • Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
  • Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
  • Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
  • Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
  • History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
  • Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.
  • Presenting with immune suppression (e.g. autoimmune disease, HIV), as assessed by Investigator.
  • Has undergone surgery in the last 3 months, or has surgery planned during the trial period, as assessed by Investigator.
  • Uses concomitant medications including natural health products (excluding contraceptives and PRN or other medications, which in the Investigator's opinion, do not affect the trial outcomes or participant safety).
  • Currently following a regimented or restricted diet which in the opinion of the Nutritionist and/or PI would negatively affect the study outcome or participants' ability to comply with study requirements, or has in the 3 months prior to enrollment.
  • Plans to change dietary habits and/or activity level during the trial period.
  • Frequent consumption of alcohol (> 2 standard servings of alcohol/day on average).
  • History of (assessed by PI) or current tobacco use (verified by positive cotinine urinalysis)
  • Positive urinalysis for drugs of abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
  • Presenting a niacin deficiency, as assessed by Nutritionist's dietary assessment at screening, and Investigator's physical examination.
  • Has difficulty swallowing capsules.
  • Inability to provide blood and/or urine samples.
  • Positive pregnancy test, intent to get pregnant, or breastfeeding.
  • Any other condition that, in the opinion of the Investigator, could impair the Investigator's ability to complete the study outcomes and participant safety. Participating simultaneously in another clinical research protocol or having participated in another research study for which the exclusion period would not be completed

Treatment and study plan

Nicotinamide mononucleotide (NMN-C)

Dietary Supplement

Daily supplementation with NMN-C at 400 mg for 29 days in total

Primary outcomes

  1. Safety as measured by subject incident of treatment-emergent adverse events

    Time frame: between Day 1 and Day 30

    Subject incidence of treatment-emergent adverse events

  2. Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs

    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)

  3. Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.

    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)

Secondary outcomes

  1. Change from baseline in NAD+ and NMN concentrations in whole blood

    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

  2. Change from baseline in NAD+ and NMN concentrations in whole blood

    Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30

    NAD+ and NMN will be assessed in blood

  3. Change from baseline in NAD+ metabolites concentrations 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 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

  4. Change from baseline in NAD+ metabolites concentrations in plasma

    Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30

    MeNAM and NAM will be assessed in plasma

  5. Change from baseline in NAD+ metabolites concentrations in urine

    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

  6. Change from baseline in NAD+ metabolites concentrations in urine

    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

  7. Change from baseline in NAD+ and NMN concentrations in whole blood

    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

  8. Change from baseline in NAD+ metabolites concentrations in plasma

    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

  9. Change from baseline in NAD+ metabolites concentrations in urine

    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

  10. Changes in body weight

    Time frame: Day 1, Day 29

  11. Tolerance

    Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30

    The number of participants with Adverse Events

  12. Changes in Quality of life

    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)

  13. Changes in Sleep quality

    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)

  14. Changes in Fatigue state

    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).

  15. Change in blood lipid profile from baseline during the intervention period

    Time frame: Day 1, Day 29

    Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated

  16. Change in blood glucose (fasting) from baseline during the intervention period

    Time frame: Day 1, Day 29

    the McNair Cognitive Difficulty Self Questionnaire

  17. Change from baseline in homocysteine concentrations

    Time frame: Day 1, Day 29

    homocysteine level will be evaluated in plasma

Sponsors and collaborators

Lead sponsor

Seneque SA

Industry

Collaborators

  • Dicentra Inc.
  • LGD

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 2, 2021
Registry last updated
Mar 30, 2023

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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