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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862338
Recruitment Status : Completed
First Posted : April 28, 2021
Last Update Posted : January 26, 2023
Sponsor:
Collaborators:
CEN Biotech
LGD
Information provided by (Responsible Party):
Seneque SA

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Nicotinamide mononucleotide (NMN-C) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
Actual Study Start Date : April 26, 2021
Actual Primary Completion Date : September 8, 2021
Actual Study Completion Date : April 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nicotinamide mononucleotide (NMN-C)
Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
 Dietary Supplement: Nicotinamide mononucleotide (NMN-C)
Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in NAD+ concentrations in whole blood [ Time Frame: Day 0, Day 14 and Day 28 ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862338


Locations
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France
Biomed 21
Dijon, France, 21000
Sponsors and Collaborators
Seneque SA
CEN Biotech
LGD
More Information
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Responsible Party: Seneque SA
ClinicalTrials.gov Identifier: NCT04862338    
Other Study ID Numbers: C1677
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seneque SA:
tolerance
Pharmacodynamics
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
 Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents