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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Nicotinamide mononucleotide (NMN-C)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotinamide mononucleotide (NMN-C)<br>Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total | Dietary Supplement: Nicotinamide mononucleotide (NMN-C)<br>* Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tolerance, Pharmacodynamics