Physical ActivityNCT04664361
Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
A study testing Nicotinamide mononucleotide in people with Physical Activity and Muscle Recovery, run by Seneque SA at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in… Read more about this study
- Who is it for?
- Ages 20 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Muscle Recovery
- What is being tested?
- Nicotinamide mononucleotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2021to 30 May 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 20 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index ranging from 20 to 28 kg/m2(bounds included);
- Body weight between of 70 kg to 100 kg (including limits);
- Able to provide written informed consent to participate;
- Having a moderate level of physical activity according to the Global Physical Activity Questionnaire (GPAQ);
- Having a sport practice involving endurance or split races (including collective or individual sports) or cycling.
- Agreeing not to change their physical activity habits throughout the study;
Who cannot join
- Having a mental state that does not allow them to give free and informed consent to participate in the study;
- Being taking regularly or have taken within the last month any medication or dietary supplement that may increase endurance, recovery, or physical capacity. In particular, the following drugs are strictly prohibited: beta-2 agonists such as salbutamol (Ventolin®), terbutaline (Bricanyl®), fenoterol (Berotec®), salmeterol (Serevent®) and formoterol (Foradil®) as well as corticosteroids;
- Having history of a recent (less than 3 months) lower extremity muscle injury;
- Presenting a depressive syndrome;
- Presenting, in the opinion of the investigator, any symptomatology, pathology or cardiovascular risk factors that are incompatible with the conduct of the study or with the performance of a stress test or that could influence the results of the study, and in particular: 1) an abnormal resting and/or stress ECG at the inclusion visit according to the investigator; 2) presence of abnormalities in the lipid balance (Total Cholesterol, Triglycerides, HDL, LDL), blood glucose, and/or hemodynamic parameters;
- Presenting an abnormal biological balance (Creatinine, Uric acid, Troponin, Alanine aminotransferase / Aspartate aminotransferase, Lactate dehydrogenase, Creatine Kinase, C-reactive protein, Transferrin, Bilirubin, Gamma Glutamyl transpeptidase, Cholesterol (EAL), Glycemia, Ionogram, Alkaline phosphatase );
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- Being not be compliant with the constraints imposed by the protocol;
- Having an allergy or a contraindication to the components of the studied products;
- Being already involved in another clinical trial or being in the exclusion period of a previous clinical trial;
- Being unable to understand, speak and read French fluently;
- Being not affiliated with a health insurance company;
- Being vulnerable persons or persons deprived of liberty by a judicial or administrative decision;
- Consuming illegal psychotropic substances or having an alcohol consumption of more than 2 glasses of alcohol/wine per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.
- Conditions
- Physical Activity, Muscle Recovery
- Being tested
- Nicotinamide mononucleotide, Placebo
- Keywords
- Nicotinamide mononucleotide, Muscle pain
- Medical subject headings
- Motor Activity, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide mononucleotideDietary supplement
Daily supplementation with NMN at 250 and 500 mg for 38 days in total
PlaceboOther
Daily supplementation with placebo for 38 days in total
| Study group | Role | What they receive |
|---|---|---|
| NMN 250 | Experimental | NMN tablet (250 mg) Receives: Dietary Supplement: Nicotinamide mononucleotide |
| NMN 500 | Experimental | NMN tablet (500 mg) Receives: Dietary Supplement: Nicotinamide mononucleotide |
| Placebo | Placebo comparator | NMN-free placebo tablet. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of muscle recovery
Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)
Measured: before and after 21 and 38 days of treatment
Secondary outcomes (7)
Changes in physical capacity
physical capacity evaluated during an endurance test (at 85% maximum aerobic speed) by the maximum duration (time limit)
Measured: before and after 21 and 38 days of treatment
Changes in cardiorespiratory recovery
Measurement of blood pressure and heart rate at rest and at intervals of several minutes after the endurance test (at 85% maximum aerobic speed)
Measured: before and after 21 and 38 days of treatment
Changes in the perception of the arduousness of the effort
evaluated by the Borg scale during the endurance test (at 85% maximum aerobic speed)
Measured: before and after 21 and 38 days of treatment
Changes in blood lactate levels before and after physical exercise
blood lactate levels before and after the endurance test (at 85% maximum aerobic speed)
Measured: before and after 21 and 38 days of treatment
Changes in the perception of the intensity of post-exercise muscle pain (cramps)
post-exercise muscular pain in evaluated using a 7 points numerical scale, 24, 48 and 72 hours after the endurance test
Measured: before and after 21 and 38 days of treatment
Changes in the body composition
fat mass, muscle mass, visceral fat, water mass determined by Bioelectrical Impedance Analysis (BIA)
Measured: before and after 21 and 38 days of treatment
Changes blood NAD+ levels
Evaluation of cellular NAD+ concentration in blood from baseline to the end of study
Measured: before and after 21 and 38 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start9 Mar 2021
- Primary completion10 Nov 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seneque SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Nutriment, Centre d'Expertise de la Performance, LGD
- Responsible party
- Sponsor
- Investigators
- Nadège PLAZA, MD, Principal investigator, CEN Nutriment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664361
- Sponsor's protocol ID
- C1598
- Status last verified
- Jan 2024
- First submitted
- 10 Dec 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
- ClinicalTrials.gov ID
- NCT04664361
- Acronym / sponsor ID
- C1598
- Conditions
- Physical Activity, Muscle Recovery
- Keywords
- Nicotinamide mononucleotide, Muscle pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Seneque SAIndustry (pharma, biotech, devices)
- Collaborators
- CEN Nutriment, Centre d'Expertise de la Performance, LGD
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Dec 2020 (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 effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
| Arm | Type | Receives |
|---|---|---|
| NMN 250 | Experimental | Dietary Supplement: Nicotinamide mononucleotideNMN tablet (250 mg) |
| NMN 500 | Experimental | Dietary Supplement: Nicotinamide mononucleotideNMN tablet (500 mg) |
| Placebo | Placebo comparator | Other: PlaceboNMN-free placebo tablet. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body Mass Index ranging from 20 to 28 kg/m2(bounds included);
- Body weight between of 70 kg to 100 kg (including limits);
- Able to provide written informed consent to participate;
- Having a moderate level of physical activity according to the Global Physical Activity Questionnaire (GPAQ);
- Having a sport practice involving endurance or split races (including collective or individual sports) or cycling.
Key exclusion criteria (13 listed)
- Having a mental state that does not allow them to give free and informed consent to participate in the study;
- Being taking regularly or have taken within the last month any medication or dietary supplement that may increase endurance, recovery, or physical capacity. In particular, the following drugs are strictly prohibited: beta-2 agonists such as salbutamol (Ventolin®), terbutaline (Bricanyl®), fenoterol (Berotec®), salmeterol (Serevent®) and formoterol (Foradil®) as well as corticosteroids;
- Having history of a recent (less than 3 months) lower extremity muscle injury;
- Presenting a depressive syndrome;
- Presenting, in the opinion of the investigator, any symptomatology, pathology or cardiovascular risk factors that are incompatible with the conduct of the study or with the performance of a stress test or that could influence the results of the study, and in particular: 1) an abnormal resting and/or stress ECG at the inclusion visit according to the investigator; 2) presence of abnormalities in the lipid balance (Total Cholesterol, Triglycerides, HDL, LDL), blood glucose, and/or hemodynamic parameters;
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 mononucleotideDaily supplementation with NMN at 250 and 500 mg for 38 days in total | Dietary supplement | NMN 250, NMN 500 |
| PlaceboDaily supplementation with placebo for 38 days in total | Other | Placebo |
Primary outcome
Evolution of muscle recovery
Time frame: before and after 21 and 38 days of treatment
Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)
7 secondary outcomes
Changes in physical capacity
Time frame: before and after 21 and 38 days of treatment
Changes in cardiorespiratory recovery
Time frame: before and after 21 and 38 days of treatment
Changes in the perception of the arduousness of the effort
Time frame: before and after 21 and 38 days of treatment
Changes in blood lactate levels before and after physical exercise
Time frame: before and after 21 and 38 days of treatment
Changes in the perception of the intensity of post-exercise muscle pain (cramps)
Time frame: before and after 21 and 38 days of treatment
Changes in the body composition
Time frame: before and after 21 and 38 days of treatment
Changes blood NAD+ levels
Time frame: before and after 21 and 38 days of treatment
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 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Nadège PLAZA, MD principal investigator
CEN Nutriment
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 in people with Physical Activity and Muscle Recovery, 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 6 inclusion and 13 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 17 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Evolution of muscle recovery (time frame: before and after 21 and 38 days of treatment). 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 17 Jan 2024.