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| Name | Class |
|---|---|
| CEN Biotech | INDUSTRY |
| LGD | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide mononucleotide (NMN-C) | Experimental | Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide mononucleotide (NMN-C) | Dietary Supplement | Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in NAD+ concentrations in whole blood | Day 0, Day 14 and Day 28 |
| 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 |
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Inclusion Criteria:
Healthy volunteers should be
Exclusion Criteria:
May not be included in the study Volunteers with
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomed 21 | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D009537 | Nicotinamide Mononucleotide |
| ID | Term |
|---|---|
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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Exploratory interventional repeated-dose study, open-label, single-arm, single-center
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| 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 |