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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01687361
First received: June 20, 2012
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Neuromuscular Electrical Stimulation
Dietary Supplement: branched-chain amino acids (BCAA) supplementation
Drug: PLACEBO

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • evaluation of the muscular responsiveness [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluation of the effects of a supplementation in AAB [ Time Frame: 24 MONTTHS ] [ Designated as safety issue: No ]
    on the physiological aspects


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: branched-chain amino acids (BCAA) supplementation Dietary Supplement: branched-chain amino acids (BCAA) supplementation
Placebo Comparator: PLACEBO Drug: PLACEBO

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687361

Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Principal Investigator: jean pierre mattei AP HM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01687361     History of Changes
Other Study ID Numbers: 2012-A00449-34, 2012-04
Study First Received: June 20, 2012
Last Updated: August 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on November 27, 2014