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OpenTrials
Completed

NCT Number: NCT04862338

Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults

The purpose of this study is to evaluate the physiological and/or biological actions of nicotinamide mononucleotide (NMN-C) in healthy adults receiving a repeated-dose over the course of 28 days by studying the tolerance and pharmacodynamics of this product.

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Key information

Conditions

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomed 21

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy volunteers should be

  • Men between the ages of 30 and 60 years old
  • With a BMI between 23 and 30 kg/m2
  • With a weight > or = 70kg
  • Giving their free informed consent to the study

Exclusion criteria

May not be included in the study Volunteers with

  • a history of allergy to vitamin B3 (niacin or nicotinamide)
  • immunocompromised or suffering from a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic or infectious)
  • with abnormal results on the screening bioassay (CBC, Transaminases (AST, ALT, GGT), Bilirubin, Creatinine, CPK, Ionogram, Blood glucose, Hba1c, Lipid profile)
  • having donated blood in the month preceding inclusion,
  • having consumed more than 2 glasses of alcohol per day,
  • being under medication or taking food supplements,
  • having reached the maximum compensation threshold for research involving the human being as provided for by the regulations or having participated in another biomedical research project that required blood samples in the previous month,
  • involved in another clinical trial or being in the exclusion period of a previous clinical trial.

Treatment and study plan

Nicotinamide mononucleotide (NMN-C)

Dietary Supplement

Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total

Primary outcomes

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

    Time frame: Day 0, Day 14 and Day 28

Secondary outcomes

  1. Change from baseline in NMN concentrations in whole blood

    Time frame: Day 0, Day 14 and Day 28

  2. Change from baseline NAD+ metabolite concentrations in plasma

    Time frame: Day 0, Day 14 and Day 28

    MeNAM, NAM, DMG, TMG and Homocystein

  3. Change from baseline NAD+ metabolite concentrations in urine

    Time frame: Day -7, Day 14 and Day 28

    MeNAM and Me-2-PY

  4. Adverse events

    Time frame: Day 14 and Day 28

    Evaluation of adverse events

  5. Evolution of the mitochondrial DNA ratio

    Time frame: Day 0 and Day 28

    mitochondrial DNA ratio will be assessed in the epithelial cells collected by buccal swabs

  6. Evolution of blood glucose levels

    Time frame: Day -7, Day 14 and Day 28

  7. Evolution of blood lipid levels

    Time frame: Day -7, Day 14 and Day 28

    Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol

  8. Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood

    Time frame: Day -7, Day 14 and Day 28

  9. Evolution of Blood cell count

    Time frame: Day -7, Day 14 and Day 28

  10. Evolution of Bilirubin levels in blood

    Time frame: Day -7, Day 14 and Day 28

  11. Evolution of Creatinine levels in blood

    Time frame: Day -7, Day 14 and Day 28

  12. Creatine phosphokinase (CPK) levels in blood

    Time frame: Day -7, Day 14 and Day 28

  13. Evolution of blood Ionogram

    Time frame: Day -7, Day 14 and Day 28

    Potassium, Chloride, Sodium levels will be assessed in blood

  14. Evolution of Diastolic blood pressure

    Time frame: Day -7 and Day 28

  15. Evolution of Systolic blood pressure

    Time frame: Day -7 and Day 28

  16. Evolution of Heart rate

    Time frame: Day -7 and Day 28

  17. Evolution of weight

    Time frame: Day -7, Day 14 and Day 28

  18. Evolution of body composition

    Time frame: Day -7, Day 14 and Day 28

    Body composition will be assessed by impedancemetry

Sponsors and collaborators

Lead sponsor

Seneque SA

Industry

Collaborators

  • CEN Biotech
  • LGD

Registry information

Official study title

Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Jan 26, 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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