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

Sponsor
Seneque SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04664361
Collaborator
CEN Nutriment (Other), Centre d'Expertise de la Performance (Other), LGD (Industry)
150
1
3
26.7
5.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nicotinamide mononucleotide
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groupsRandomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NMN 250

NMN tablet (250 mg)

Dietary Supplement: Nicotinamide mononucleotide
Daily supplementation with NMN at 250 and 500 mg for 38 days in total

Experimental: NMN 500

NMN tablet (500 mg)

Dietary Supplement: Nicotinamide mononucleotide
Daily supplementation with NMN at 250 and 500 mg for 38 days in total

Placebo Comparator: Placebo

NMN-free placebo tablet.

Other: Placebo
Daily supplementation with placebo for 38 days in total

Outcome Measures

Primary Outcome Measures

  1. Evolution of muscle recovery [before and after 21 and 38 days of treatment]

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

Secondary Outcome Measures

  1. Changes in physical capacity [before and after 21 and 38 days of treatment]

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

  2. Changes in cardiorespiratory recovery [before and after 21 and 38 days of treatment]

    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 [before and after 21 and 38 days of treatment]

    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 [before and after 21 and 38 days of treatment]

    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) [before and after 21 and 38 days of treatment]

    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 [before and after 21 and 38 days of treatment]

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

  7. Changes blood NAD+ levels [before and after 21 and 38 days of treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 49 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CEN Nutriment Dijon France 21000

Sponsors and Collaborators

  • Seneque SA
  • CEN Nutriment
  • Centre d'Expertise de la Performance
  • LGD

Investigators

  • Principal Investigator: Nadège PLAZA, MD, CEN Nutriment

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seneque SA
ClinicalTrials.gov Identifier:
NCT04664361
Other Study ID Numbers:
  • C1598
First Posted:
Dec 11, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seneque SA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022