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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT04862338 (opens ClinicalTrials.gov in a new tab)Other idC1677
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
17 participants (actual)
Sponsor
Seneque SA · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

France

Start
26 Apr 2021
Primary completion
8 Sept 2021
Completion
4 Apr 2022
First posted
28 Apr 2021
Last update posted
26 Jan 2023
Conditions
Healthy Volunteers

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. N/A

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

    NCT04862338

    26 Apr 2021 to 4 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Nicotinamide mononucleotide (NMN-C)Dietary supplement

Arms1

  • Experimental

    Nicotinamide mononucleotide (NMN-C)

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Day 0, Day 14 and Day 28

Secondary outcomes(18)

  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

    Registry description

    MeNAM, NAM, DMG, TMG and Homocystein

  3. Change from baseline NAD+ metabolite concentrations in urine

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

    Registry description

    MeNAM and Me-2-PY

  4. Adverse events

    Time frame · Day 14 and Day 28

    Registry description

    Evaluation of adverse events

  5. Evolution of the mitochondrial DNA ratio

    Time frame · Day 0 and Day 28

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Body composition will be assessed by impedancemetry

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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