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

January 25, 2023 updated by: Seneque SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Biomed 21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in NAD+ concentrations in whole blood
Time Frame: Day 0, Day 14 and Day 28
Day 0, Day 14 and Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in NMN concentrations in whole blood
Time Frame: Day 0, Day 14 and Day 28
Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in plasma
Time Frame: Day 0, Day 14 and Day 28
MeNAM, NAM, DMG, TMG and Homocystein
Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in urine
Time Frame: Day -7, Day 14 and Day 28
MeNAM and Me-2-PY
Day -7, Day 14 and Day 28
Adverse events
Time Frame: Day 14 and Day 28
Evaluation of adverse events
Day 14 and Day 28
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
Day 0 and Day 28
Evolution of blood glucose levels
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of blood lipid levels
Time Frame: Day -7, Day 14 and Day 28
Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol
Day -7, Day 14 and Day 28
Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of Blood cell count
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of Bilirubin levels in blood
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of Creatinine levels in blood
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Creatine phosphokinase (CPK) levels in blood
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of blood Ionogram
Time Frame: Day -7, Day 14 and Day 28
Potassium, Chloride, Sodium levels will be assessed in blood
Day -7, Day 14 and Day 28
Evolution of Diastolic blood pressure
Time Frame: Day -7 and Day 28
Day -7 and Day 28
Evolution of Systolic blood pressure
Time Frame: Day -7 and Day 28
Day -7 and Day 28
Evolution of Heart rate
Time Frame: Day -7 and Day 28
Day -7 and Day 28
Evolution of weight
Time Frame: Day -7, Day 14 and Day 28
Day -7, Day 14 and Day 28
Evolution of body composition
Time Frame: Day -7, Day 14 and Day 28
Body composition will be assessed by impedancemetry
Day -7, Day 14 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seneque SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEN Biotech
LGD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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