Healthy VolunteersNCT04862338
Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults
A study testing Nicotinamide mononucleotide (NMN-C) in people with Healthy Volunteers, run by Seneque SA at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nicotinamide mononucleotide (NMN-C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2021to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
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.
- Conditions
- Healthy Volunteers
- Being tested
- Nicotinamide mononucleotide (NMN-C)
- Keywords
- tolerance, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide mononucleotide (NMN-C)Dietary supplement
Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide mononucleotide (NMN-C) | Experimental | Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total Receives: Dietary Supplement: Nicotinamide mononucleotide (NMN-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NAD+ concentrations in whole blood
Measured: Day 0, Day 14 and Day 28
Secondary outcomes (18)
Change from baseline in NMN concentrations in whole blood
Measured: Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in plasma
MeNAM, NAM, DMG, TMG and Homocystein
Measured: Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in urine
MeNAM and Me-2-PY
Measured: Day -7, Day 14 and Day 28
Adverse events
Evaluation of adverse events
Measured: 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
Measured: Day 0 and Day 28
Evolution of blood glucose levels
Measured: Day -7, Day 14 and Day 28
Evolution of blood lipid levels
Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol
Measured: Day -7, Day 14 and Day 28
Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood
Measured: Day -7, Day 14 and Day 28
Evolution of Blood cell count
Measured: Day -7, Day 14 and Day 28
Evolution of Bilirubin levels in blood
Measured: Day -7, Day 14 and Day 28
Evolution of Creatinine levels in blood
Measured: Day -7, Day 14 and Day 28
Creatine phosphokinase (CPK) levels in blood
Measured: Day -7, Day 14 and Day 28
Evolution of blood Ionogram
Potassium, Chloride, Sodium levels will be assessed in blood
Measured: Day -7, Day 14 and Day 28
Evolution of Diastolic blood pressure
Measured: Day -7 and Day 28
Evolution of Systolic blood pressure
Measured: Day -7 and Day 28
Evolution of Heart rate
Measured: Day -7 and Day 28
Evolution of weight
Measured: Day -7, Day 14 and Day 28
Evolution of body composition
Body composition will be assessed by impedancemetry
Measured: Day -7, Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Apr 2021
- Primary completion8 Sep 2021
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory interventional repeated-dose study, open-label, single-arm, single-center
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seneque SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech, LGD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862338
- Sponsor's protocol ID
- C1677
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
- ClinicalTrials.gov ID
- NCT04862338
- Acronym / sponsor ID
- C1677
- Conditions
- Healthy Volunteers
- Keywords
- tolerance, Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seneque SAIndustry (pharma, biotech, devices)
- Collaborators
- CEN Biotech, LGD
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory interventional repeated-dose study, open-label, single-arm, single-center
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide mononucleotide (NMN-C) | Experimental | Dietary Supplement: Nicotinamide mononucleotide (NMN-C)Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide mononucleotide (NMN-C)Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total | Dietary supplement | Nicotinamide mononucleotide (NMN-C) |
Primary outcome
Change from baseline in NAD+ concentrations in whole blood
Time frame: Day 0, Day 14 and Day 28
18 secondary outcomes
Change from baseline in NMN concentrations in whole blood
Time frame: Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in plasma
Time frame: Day 0, Day 14 and Day 28
Change from baseline NAD+ metabolite concentrations in urine
Time frame: Day -7, Day 14 and Day 28
Adverse events
Time frame: Day 14 and Day 28
Evolution of the mitochondrial DNA ratio
Time frame: Day 0 and Day 28
Evolution of blood glucose levels
Time frame: Day -7, Day 14 and Day 28
Evolution of blood lipid levels
Time frame: Day -7, Day 14 and Day 28
Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood
Time frame: Day -7, Day 14 and Day 28
Evolution of Blood cell count
Time frame: Day -7, Day 14 and Day 28
Evolution of Bilirubin levels in blood
Time frame: Day -7, Day 14 and Day 28
Evolution of Creatinine levels in blood
Time frame: Day -7, Day 14 and Day 28
Creatine phosphokinase (CPK) levels in blood
Time frame: Day -7, Day 14 and Day 28
Evolution of blood Ionogram
Time frame: Day -7, Day 14 and Day 28
Evolution of Diastolic blood pressure
Time frame: Day -7 and Day 28
Evolution of Systolic blood pressure
Time frame: Day -7 and Day 28
Evolution of Heart rate
Time frame: Day -7 and Day 28
Evolution of weight
Time frame: Day -7, Day 14 and Day 28
Evolution of body composition
Time frame: Day -7, Day 14 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide mononucleotide (NMN-C) in people with Healthy Volunteers, run by Seneque SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NAD+ concentrations in whole blood (time frame: Day 0, Day 14 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.