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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862338
• Other study ID #: C1677
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: January 2023
• Source: Seneque SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 4, 2022
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Biomed 21	Dijon

Sponsors (3)

Lead Sponsor	Collaborator
Seneque SA	CEN Biotech, LGD

Country where clinical trial is conducted

France, 

Outcome

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