Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults
Not Applicable
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Nicotinamide mononucleotide (NMN-C)
- Registration Number
- NCT04862338
- Lead Sponsor
- Seneque SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nicotinamide mononucleotide (NMN-C) Nicotinamide mononucleotide (NMN-C) Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
- Primary Outcome Measures
Name Time Method Change from baseline in NAD+ concentrations in whole blood Day 0, Day 14 and Day 28
- Secondary Outcome Measures
Name Time Method Change from baseline in NMN concentrations in whole blood Day 0, 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 Blood cell count Day -7, Day 14 and Day 28 Evolution of Heart rate Day -7 and Day 28 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 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 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 Bilirubin levels in blood 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 Systolic blood pressure Day -7 and Day 28 Evolution of body composition Day -7, Day 14 and Day 28 Body composition will be assessed by impedancemetry
Evolution of weight Day -7, Day 14 and Day 28
Trial Locations
- Locations (1)
Biomed 21
🇫🇷Dijon, France