Neuromuscular Electrical StimulationNCT01687361
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
A study testing branched-chain amino acids (BCAA) supplementation in people with Neuromuscular Electrical Stimulation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Electrical Stimulation
- What is being tested?
- branched-chain amino acids (BCAA) supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Conditions
- Neuromuscular Electrical Stimulation
- Being tested
- branched-chain amino acids (BCAA) supplementation, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
branched-chain amino acids (BCAA) supplementationDietary supplement
PLACEBODrug
| Study group | Role | What they receive |
|---|---|---|
| branched-chain amino acids (BCAA) supplementation | Experimental | Not described Receives: Dietary Supplement: branched-chain amino acids (BCAA) supplementation |
| PLACEBO | Placebo comparator | Not described Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the muscular responsiveness
Measured: 24 MONTHS
Secondary outcomes (1)
evaluation of the effects of a supplementation in AAB
on the physiological aspects
Measured: 24 MONTTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseillejean pierre mattei, Principal investigator, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687361
- Sponsor's protocol ID
- 2012-A00449-34
- Other IDs
- 2012-04
- Status last verified
- Aug 2014
- First submitted
- 20 Jun 2012
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01687361
- Acronym / sponsor ID
- 2012-A00449-34
- Conditions
- Neuromuscular Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| branched-chain amino acids (BCAA) supplementation | Experimental | Dietary Supplement: branched-chain amino acids (BCAA) supplementation |
| PLACEBO | Placebo comparator | Drug: PLACEBO |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male
- Between 18 and 35 years
- Subjects will have to be unhurt:
- They will have to follow no chronic treatment
- They will have to be unhurt of any history of alcoholism or drug addiction
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| branched-chain amino acids (BCAA) supplementation | Dietary supplement | branched-chain amino acids (BCAA) supplementation |
| PLACEBO | Drug | PLACEBO |
Primary outcome
evaluation of the muscular responsiveness
Time frame: 24 MONTHS
1 secondary outcome
evaluation of the effects of a supplementation in AAB
Time frame: 24 MONTTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
jean pierre mattei principal investigator
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing branched-chain amino acids (BCAA) supplementation in people with Neuromuscular Electrical Stimulation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the muscular responsiveness (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.