Healthy Volunteers
Conditions
Keywords
tolerance, Pharmacodynamics
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.
Interventions
DIETARY_SUPPLEMENTNicotinamide mononucleotide (NMN-C)
Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
Sponsors
CEN Biotech
LGD
Seneque SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in NAD+ concentrations in whole blood | Day 0, Day 14 and Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline NAD+ metabolite concentrations in plasma | Day 0, Day 14 and Day 28 | MeNAM, NAM, DMG, TMG and Homocystein |
| Change from baseline NAD+ metabolite concentrations in urine | Day -7, Day 14 and Day 28 | MeNAM and Me-2-PY |
| Adverse events | Day 14 and Day 28 | Evaluation of adverse events |
| Evolution of the mitochondrial DNA ratio | Day 0 and Day 28 | mitochondrial DNA ratio will be assessed in the epithelial cells collected by buccal swabs |
| Evolution of blood glucose levels | Day -7, Day 14 and Day 28 | — |
| Evolution of blood lipid levels | Day -7, Day 14 and Day 28 | Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol |
| 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 | — |
| Change from baseline in NMN concentrations in whole blood | Day 0, 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 | Day -7, Day 14 and Day 28 | Potassium, Chloride, Sodium levels will be assessed in blood |
| 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 | Day -7, Day 14 and Day 28 | Body composition will be assessed by impedancemetry |
| Evolution of Bilirubin levels in blood | Day -7, Day 14 and Day 28 | — |
Countries
France
Outcome results
None listed