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Trial · Interventional

CompletedNot applicableRegistry data

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

Overview

Status
Completed
Phase
Not applicable
Enrollment
131 participants (actual)
Sponsor
Seneque SA · Industry
Design
Randomized · Quadruple masking
Countries
1 country

France

Start
9 Mar 2021
Primary completion
10 Nov 2022
Completion
30 May 2023
First posted
11 Dec 2020
Last update posted
17 Jan 2024
Conditions
Physical Activity · Muscle Recovery

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. N/A

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

    NCT04664361

    9 Mar 2021 to 30 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Nicotinamide mononucleotideDietary supplement
  • PlaceboOther

Arms3

  • Experimental

    NMN 250

    NMN tablet (250 mg)

  • Experimental

    NMN 500

    NMN tablet (500 mg)

  • Placebo comparator

    Placebo

    NMN-free placebo tablet.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Evolution of muscle recovery

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)

Secondary outcomes(7)
  1. Changes in physical capacity

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    physical capacity evaluated during an endurance test (at 85% maximum aerobic speed) by the maximum duration (time limit)

  2. Changes in cardiorespiratory recovery

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    Measurement of blood pressure and heart rate at rest and at intervals of several minutes after the endurance test (at 85% maximum aerobic speed)

  3. Changes in the perception of the arduousness of the effort

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    evaluated by the Borg scale during the endurance test (at 85% maximum aerobic speed)

  4. Changes in blood lactate levels before and after physical exercise

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    blood lactate levels before and after the endurance test (at 85% maximum aerobic speed)

  5. Changes in the perception of the intensity of post-exercise muscle pain (cramps)

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    post-exercise muscular pain in evaluated using a 7 points numerical scale, 24, 48 and 72 hours after the endurance test

  6. Changes in the body composition

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    fat mass, muscle mass, visceral fat, water mass determined by Bioelectrical Impedance Analysis (BIA)

  7. Changes blood NAD+ levels

    Time frame · before and after 21 and 38 days of treatment

    Registry description

    Evaluation of cellular NAD+ concentration in blood from baseline to the end of study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 49 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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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