Clinical trial NCT04862338: Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults
Official title: Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: tolerance
Pharmacodynamics
Lead sponsor: Seneque SA
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
name: LGD
First posted: 2021-04-28
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in NAD+ concentrations in whole blood
timeFrame: Day 0, Day 14 and Day 28
Secondary outcomes:
measure: Change from baseline in NMN concentrations in whole blood
timeFrame: Day 0, Day 14 and Day 28
measure: Change from baseline NAD+ metabolite concentrations in plasma
timeFrame: Day 0, Day 14 and Day 28
measure: Change from baseline NAD+ metabolite concentrations in urine
timeFrame: Day -7, Day 14 and Day 28
measure: Adverse events
timeFrame: Day 14 and Day 28
measure: Evolution of the mitochondrial DNA ratio
timeFrame: Day 0 and Day 28
measure: Evolution of blood glucose levels
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of blood lipid levels
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of Blood cell count
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of Bilirubin levels in blood
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of Creatinine levels in blood
timeFrame: Day -7, Day 14 and Day 28
measure: Creatine phosphokinase (CPK) levels in blood
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of blood Ionogram
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of Diastolic blood pressure
timeFrame: Day -7 and Day 28
measure: Evolution of Systolic blood pressure
timeFrame: Day -7 and Day 28
measure: Evolution of Heart rate
timeFrame: Day -7 and Day 28
measure: Evolution of weight
timeFrame: Day -7, Day 14 and Day 28
measure: Evolution of body composition
timeFrame: Day -7, Day 14 and Day 28
Other outcomes:
Locations:
city: Dijon
country: France
facility: Biomed 21
Study officials:
References: