NCT04862338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

April 21, 2021

Last Update Submit

January 25, 2023

Conditions

Healthy Volunteers

Keywords

tolerancePharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in NAD+ concentrations in whole blood

    Day 0, Day 14 and Day 28

Secondary Outcomes (18)

  • Change from baseline in NMN concentrations in whole blood

    Day 0, Day 14 and Day 28

  • Change from baseline NAD+ metabolite concentrations in plasma

    Day 0, Day 14 and Day 28

  • Change from baseline NAD+ metabolite concentrations in urine

    Day -7, Day 14 and Day 28

  • Adverse events

    Day 14 and Day 28

  • Evolution of the mitochondrial DNA ratio

    Day 0 and Day 28

  • +13 more secondary outcomes

Study Arms (1)

Nicotinamide mononucleotide (NMN-C)

EXPERIMENTAL

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

Dietary Supplement: Nicotinamide mononucleotide (NMN-C)

Interventions

Nicotinamide mononucleotide (NMN-C)DIETARY_SUPPLEMENT

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

Nicotinamide mononucleotide (NMN-C)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomed 21

Dijon, 21000, France

Location

MeSH Terms

Interventions

Nicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

RibonucleotidesNucleotidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 28, 2021

Study Start

April 26, 2021

Primary Completion

September 8, 2021

Study Completion

April 4, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)