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

NCT ID: NCT04862338

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nicotinamide mononucleotide (NMN-C)

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

Group Type EXPERIMENTAL

Nicotinamide mononucleotide (NMN-C)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotinamide mononucleotide (NMN-C)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CEN Biotech

INDUSTRY

Sponsor Role collaborator

LGD

INDUSTRY

Sponsor Role collaborator

Seneque SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Biomed 21

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C1677

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NR Supplementation and Exercise
NCT04907110 COMPLETED NA