Healthy VolunteersNCT04910061
Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
A study testing Nicotinamide mononucleotide (NMN-C) in people with Healthy Volunteers, run by Seneque SA at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and… Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2021to 1 Mar 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
- Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
- BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
- Having given written informed consent to participate in the research trial.
- Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)
Who cannot join
- Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
- Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
- Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
- Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
- Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
- History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
Show all 20Show fewer
- Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.
- Presenting with immune suppression (e.g. autoimmune disease, HIV), as assessed by Investigator.
- Has undergone surgery in the last 3 months, or has surgery planned during the trial period, as assessed by Investigator.
- Uses concomitant medications including natural health products (excluding contraceptives and PRN or other medications, which in the Investigator's opinion, do not affect the trial outcomes or participant safety).
- Currently following a regimented or restricted diet which in the opinion of the Nutritionist and/or PI would negatively affect the study outcome or participants' ability to comply with study requirements, or has in the 3 months prior to enrollment.
- Plans to change dietary habits and/or activity level during the trial period.
- Frequent consumption of alcohol (> 2 standard servings of alcohol/day on average).
- History of (assessed by PI) or current tobacco use (verified by positive cotinine urinalysis)
- Positive urinalysis for drugs of abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
- Presenting a niacin deficiency, as assessed by Nutritionist's dietary assessment at screening, and Investigator's physical examination.
- Has difficulty swallowing capsules.
- Inability to provide blood and/or urine samples.
- Positive pregnancy test, intent to get pregnant, or breastfeeding.
- Any other condition that, in the opinion of the Investigator, could impair the Investigator's ability to complete the study outcomes and participant safety. Participating simultaneously in another clinical research protocol or having participated in another research study for which the exclusion period would not be completed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre Trial to Investigate the Safety and Pharmacokinetics of Orally Administered Nicotinamide Mononucleotide (NMN, 400mg) Over 29 Days of Supplementation in Healthy Adults.
The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.
- Conditions
- Healthy Volunteers
- Being tested
- Nicotinamide mononucleotide (NMN-C)
- Keywords
- safety, pharmacokinetics
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
Daily supplementation with NMN-C at 400 mg for 29 days in total
| Study group | Role | What they receive |
|---|---|---|
| NMN-C | Experimental | Healthy individuals receiving NMN-C Receives: Dietary Supplement: Nicotinamide mononucleotide (NMN-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by subject incident of treatment-emergent adverse events
Subject incidence of treatment-emergent adverse events
Measured: between Day 1 and Day 30
Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)
Measured: between Day 1 and Day 30
Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete blood count, C reactive protein, AST, ALT, bilirubin, GGT, Alkaline phosphatase, creatinine, creatine kinase, Sodium, Potassium, Chloride)
Measured: between Day 1 and Day 30
Secondary outcomes (17)
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood
Measured: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma
Measured: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine
Measured: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ and NMN concentrations in whole blood
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in plasma
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in urine
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Measured: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Changes in body weight
Measured: Day 1, Day 29
Tolerance
The number of participants with Adverse Events
Measured: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Changes in Quality of life
the mean changes in the the generic Quality of Life Self-Assessment Questionnaire SF-36 questionnaire score (The SF-36 questionnaire is scaled from a 0 to 100. The lower the score the more disability)
Measured: Day 1, Day 29
Changes in Sleep quality
the mean changes in the Sleep Quality Scale (SQS) score (SQS is providing an overall score ranging from 0 to 84, where lower scores denote a healthier sleep quality)
Measured: Day 1, Day 29
Changes in Fatigue state
the mean changes in the Multidimensional Fatigue Inventory (MFI-20) score (MFI-20 is providing an overall score ranging from 20 to 100 (a higher score indicates a higher level of fatigue).
Measured: Day 1, Day 29
Change in blood lipid profile from baseline during the intervention period
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated
Measured: Day 1, Day 29
Change in blood glucose (fasting) from baseline during the intervention period
the McNair Cognitive Difficulty Self Questionnaire
Measured: Day 1, Day 29
Change from baseline in homocysteine concentrations
homocysteine level will be evaluated in plasma
Measured: Day 1, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start5 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Mar 2023
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
- A single-arm, non-randomized, non-controlled, monocenter repeated-dose study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seneque SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., LGD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910061
- Sponsor's protocol ID
- 20-NNHSP-01
- Status last verified
- Mar 2023
- First submitted
- 10 May 2021
- Last updated
- 30 Mar 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Trial to Investigate the Safety and Pharmacokinetics of Orally Administered Nicotinamide Mononucleotide (NMN, 400mg) Over 29 Days of Supplementation in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04910061
- Acronym / sponsor ID
- 20-NNHSP-01
- Conditions
- Healthy Volunteers
- Keywords
- safety, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seneque SAIndustry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., LGD
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 2 Jun 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 investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, non-randomized, non-controlled, monocenter repeated-dose study
| Arm | Type | Receives |
|---|---|---|
| NMN-C | Experimental | Dietary Supplement: Nicotinamide mononucleotide (NMN-C)Healthy individuals receiving NMN-C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
- Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
- BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
- Having given written informed consent to participate in the research trial.
- Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)
Key exclusion criteria (20 listed)
- Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
- Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
- Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
- Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
- Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
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)Daily supplementation with NMN-C at 400 mg for 29 days in total | Dietary supplement | NMN-C |
Primary outcome
Safety as measured by subject incident of treatment-emergent adverse events
Time frame: between Day 1 and Day 30
Subject incidence of treatment-emergent adverse events
Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
Time frame: between Day 1 and Day 30
Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)
Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Time frame: between Day 1 and Day 30
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete blood count, C reactive protein, AST, ALT, bilirubin, GGT, Alkaline phosphatase, creatinine, creatine kinase, Sodium, Potassium, Chloride)
17 secondary outcomes
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ metabolites concentrations in urine
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Change from baseline in NAD+ metabolites concentrations in urine
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Change from baseline in NAD+ metabolites concentrations in urine
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Changes in body weight
Time frame: Day 1, Day 29
Tolerance
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Changes in Quality of life
Time frame: Day 1, Day 29
Changes in Sleep quality
Time frame: Day 1, Day 29
Changes in Fatigue state
Time frame: Day 1, Day 29
Change in blood lipid profile from baseline during the intervention period
Time frame: Day 1, Day 29
Change in blood glucose (fasting) from baseline during the intervention period
Time frame: Day 1, Day 29
Change from baseline in homocysteine concentrations
Time frame: Day 1, Day 29
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 30 Mar 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 Canada.
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 20 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 30 Mar 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 Canada. 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?
Safety as measured by subject incident of treatment-emergent adverse events (time frame: between Day 1 and Day 30). The study lists 3 primary outcomes in all. 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 30 Mar 2023.