Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    150
  • sponsor
    Seneque SA
Updated on 31 March 2021

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 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.

Details
Condition Physical activity, Muscle Recovery
Treatment Placebo, Nicotinamide mononucleotide, Nicotinamide mononucleotide
Clinical Study IdentifierNCT04664361
SponsorSeneque SA
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 )
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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