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

• Sponsor: Seneque SA (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04862338
• Collaborator: CEN Biotech (Industry), LGD (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.2
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Dietary Supplement: Nicotinamide mononucleotide (NMN-C)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Exploratory interventional repeated-dose study, open-label, single-arm, single-centerExploratory interventional repeated-dose study, open-label, single-arm, single-center
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
• Actual Study Start Date: Apr 26, 2021
• Actual Primary Completion Date: Jul 15, 2021
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nicotinamide mononucleotide (NMN-C) Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total	Dietary Supplement: Nicotinamide mononucleotide (NMN-C); Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total

Outcome Measures

Primary Outcome Measures

1. Change from baseline in NAD+ concentrations in whole blood [Day 0, Day 14 and Day 28]

Secondary Outcome Measures

1. Change from baseline in NMN concentrations in whole blood [Day 0, Day 14 and Day 28]

2. Change from baseline NAD+ metabolite concentrations in plasma [Day 0, Day 14 and Day 28]

   MeNAM, NAM, DMG, TMG and Homocystein

3. Change from baseline NAD+ metabolite concentrations in urine [Day -7, Day 14 and Day 28]

   MeNAM and Me-2-PY

4. Adverse events [Day 14 and Day 28]

   Evaluation of adverse events

5. 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

6. Evolution of blood glucose levels [Day -7, Day 14 and Day 28]

7. Evolution of blood lipid levels [Day -7, Day 14 and Day 28]

   Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol

8. Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood [Day -7, Day 14 and Day 28]

9. Evolution of Blood cell count [Day -7, Day 14 and Day 28]

10. Evolution of Bilirubin levels in blood [Day -7, Day 14 and Day 28]

11. Evolution of Creatinine levels in blood [Day -7, Day 14 and Day 28]

12. Creatine phosphokinase (CPK) levels in blood [Day -7, Day 14 and Day 28]

13. Evolution of blood Ionogram [Day -7, Day 14 and Day 28]

    Potassium, Chloride, Sodium levels will be assessed in blood

14. Evolution of Diastolic blood pressure [Day -7 and Day 28]

15. Evolution of Systolic blood pressure [Day -7 and Day 28]

16. Evolution of Heart rate [Day -7 and Day 28]

17. Evolution of weight [Day -7, Day 14 and Day 28]

18. Evolution of body composition [Day -7, Day 14 and Day 28]

    Body composition will be assessed by impedancemetry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biomed 21	Dijon		France	21000

Sponsors and Collaborators

• Seneque SA
• CEN Biotech
• LGD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seneque SA
• ClinicalTrials.gov Identifier: NCT04862338
• Other Study ID Numbers: C1677
• First Posted: Apr 28, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seneque SA: tolerance; Pharmacodynamics
• Additional relevant MeSH terms: Niacinamide; Niacin; Nicotinic Acids

Study Results

No Results Posted as of Jun 1, 2022