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

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: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Nicotinamide mononucleotide (NMN-C)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Biomed 21

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in NAD+ concentrations in whole blood	Day 0, Day 14 and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in NMN concentrations in whole blood		Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in plasma	MeNAM, NAM, DMG, TMG and Homocystein	Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in urine	MeNAM and Me-2-PY	Day -7, Day 14 and Day 28
Adverse events	Evaluation of adverse events	Day 14 and Day 28
Evolution of the mitochondrial DNA ratio	mitochondrial DNA ratio will be assessed in the epithelial cells collected by buccal swabs	Day 0 and Day 28
Evolution of blood glucose levels		Day -7, Day 14 and Day 28
Evolution of blood lipid levels	Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol	Day -7, Day 14 and Day 28
Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood		Day -7, Day 14 and Day 28
Evolution of Blood cell count		Day -7, Day 14 and Day 28
Evolution of Bilirubin levels in blood		Day -7, Day 14 and Day 28
Evolution of Creatinine levels in blood		Day -7, Day 14 and Day 28
Creatine phosphokinase (CPK) levels in blood		Day -7, Day 14 and Day 28
Evolution of blood Ionogram	Potassium, Chloride, Sodium levels will be assessed in blood	Day -7, Day 14 and Day 28
Evolution of Diastolic blood pressure		Day -7 and Day 28
Evolution of Systolic blood pressure		Day -7 and Day 28
Evolution of Heart rate		Day -7 and Day 28
Evolution of weight		Day -7, Day 14 and Day 28
Evolution of body composition	Body composition will be assessed by impedancemetry	Day -7, Day 14 and Day 28

Collaborators and Investigators

• Sponsor: Seneque SA
• Collaborators: CEN Biotech; LGD

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacodynamics; tolerance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID 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