- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687361
Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans
Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation ? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans.
Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in order to increase or restore muscle capacities of hypoactive patients or patients with articular trauma. Although this technique seems to be particularly adapted to muscle rehabilitation, growing evidence is emerging regarding potential damaging effects of electrically- induced isometric contractions in healthy humans. Recent studies have reported a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased muscle soreness and impaired force production as a result of NMESs. On that basis, further studies should be conducted on these deleterious effects which might limit the clinical application of NMES.
Over the last decade, many studies paid attention to branched-chain amino acids (BCAA) supplementation as a potential prophylactic/therapeutic approach. The rationale of this approach is that BCAA might increase protein synthesis and reduce protein breakdown through physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin). Additionally, BCAA could also be used as energetic substrate during exercise when glycogen stores are depleted. Overall, previous results have supported the efficacy of BCAA supplementation in attenuating muscle damage. Nevertheless, comprehensive studies investigating the effect of amino acid supplementation on markers of muscle damage are still scarce.
Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS) are powerful non invasive tools allowing the exploration of skeletal muscle structure and energy metabolism.
This ambitious project is devoted to the anatomical, functional and metabolic characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of muscle damage, including maximal voluntary force production, T2 values and apparent diffusion coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance for improving our knowledge of anatomic, metabolic and functional events related to BCAA supplementation in the context of exercise-induced muscle damage
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- Between 18 and 35 years
Subjects will have to be unhurt:
- Any general disease
- Psychiatric disorders(confusions)
- Any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology
- They will have to follow no chronic treatment
- They will have to be unhurt of any history of alcoholism or drug addiction
Exclusion Criteria:
- Contraindications for an examination MRI
- Suffering from claustrophobia
- Having stimulating one cardiac, carriers of a system Holter, carriers of hook(staple) (clip) surgical metallic, carriers of a prosthesis or a metallic implant (or quite other metallic foreign bodies), carriers of a prosthesis dental (device), carriers of a hearing aid, carriers of an insulin pump
- Having been hurt by pieces of shrapnel or lead
- Having had a dislocation, a fracture or a recent surgical operation (less than 6 months before the inclusion)
- Having followed a treatment with anti-inflammatory drugs during the last 3 months
- Having followed a treatment with amino acids during the last 3 months
- Having followed a treatment(processing) with anabolic steroids during the last 3 months
- Having participated in a program of body-building of lower limbs during the last 6 months
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: PLACEBO
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Experimental: branched-chain amino acids (BCAA) supplementation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluation of the muscular responsiveness
Time Frame: 24 MONTHS
|
24 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of the effects of a supplementation in AAB
Time Frame: 24 MONTTHS
|
on the physiological aspects
|
24 MONTTHS
|
Collaborators and Investigators
Investigators
- Principal Investigator: jean pierre mattei, AP HM
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2012-A00449-34
- 2012-04 (AP HM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuromuscular Electrical Stimulation
-
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