Muscle LossNCT01714479
Skeletal Muscle Response to Amino Acids and Load Carriage Exercise
A study testing Leucine-enriched nutritional supplement in people with Muscle Loss and Muscle Anabolism, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss, Muscle Anabolism, Muscle Performance
- What is being tested?
- Leucine-enriched nutritional supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2013
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
- Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
- Females must be on oral contraception
Who cannot join
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders
- Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
- Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
- Anemia (HCT <38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
- Musculoskeletal injuries that compromise the ability to exercise
- Blood donation within 8 weeks of enrollment
- Pregnancy and women not on oral contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage
Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.
- Conditions
- Muscle Loss, Muscle Anabolism, Muscle Performance
- Being tested
- Leucine-enriched nutritional supplement, Placebo
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine-enriched nutritional supplementOther
A protein and carbohydrate supplement with high levels of leucine
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Load Carriage - Control | Placebo comparator | Load Carriage - with a calorie-free placebo Receives: Other: Placebo |
| Load Carriage - leucine-enriched nutrition supplement | Experimental | Load Carriage with leucine-enriched amino acid supplementation Receives: Other: Leucine-enriched nutritional supplement |
| Conventional Exercise - Control | Placebo comparator | Conventional Exercise with a calorie-free placebo Receives: Other: Placebo |
| Conventional Exercise - Leucine-enriched Nutrition Supplement | Active comparator | Conventional Exercise with leucine-enriched Amino Acid supplementation Receives: Other: Leucine-enriched nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation
Measured: 90 min exercise bout (exercise) and 180 min of recovery
Secondary outcomes (1)
Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation
Measured: 4, 24, 48, and 72 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- US Army Natick Soldier Research, Development & Engineering Center
- Responsible party
- Sponsor
- Investigators
- Stefan M Pasiakos, Ph.D., Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714479
- Sponsor's protocol ID
- 12-18-HC
- Status last verified
- Sep 2016
- First submitted
- 23 Oct 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.
PubMed 28386239Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.
PubMed 26474292Margolis LM, Murphy NE, Carrigan CT, McClung HL, Pasiakos SM. Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise. Curr Dev Nutr. 2017 May 23;1(6):e000893. doi: 10.3945/cdn.117.000893. eCollection 2017 Jun.
PubMed 29955707
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage
- ClinicalTrials.gov ID
- NCT01714479
- Acronym / sponsor ID
- 12-18-HC
- Conditions
- Muscle Loss, Muscle Anabolism, Muscle Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- US Army Natick Soldier Research, Development & Engineering Center
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Oct 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.
Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Load Carriage - Control | Placebo comparator | Other: PlaceboLoad Carriage - with a calorie-free placebo |
| Load Carriage - leucine-enriched nutrition supplement | Experimental | Other: Leucine-enriched nutritional supplementLoad Carriage with leucine-enriched amino acid supplementation |
| Conventional Exercise - Control | Placebo comparator | Other: PlaceboConventional Exercise with a calorie-free placebo |
| Conventional Exercise - Leucine-enriched Nutrition Supplement | Active comparator | Other: Leucine-enriched nutritional supplementConventional Exercise with leucine-enriched Amino Acid supplementation |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
- Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
- Females must be on oral contraception
Key exclusion criteria (8 listed)
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders
- Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
- Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
- Anemia (HCT <38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
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 |
|---|---|---|
| Leucine-enriched nutritional supplementA protein and carbohydrate supplement with high levels of leucine | Other | Conventional Exercise - Leucine-enriched Nutrition Supplement, Load Carriage - leucine-enriched nutrition supplement |
| Placebo | Other | Conventional Exercise - Control, Load Carriage - Control |
Primary outcome
Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation
Time frame: 90 min exercise bout (exercise) and 180 min of recovery
1 secondary outcome
Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation
Time frame: 4, 24, 48, and 72 hours post exercise
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 21 Jul 2017.
- Background: PubMed 28386239Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.
- Results publication: PubMed 26474292Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.
- Derived from this study: PubMed 29955707Margolis LM, Murphy NE, Carrigan CT, McClung HL, Pasiakos SM. Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise. Curr Dev Nutr. 2017 May 23;1(6):e000893. doi: 10.3945/cdn.117.000893. eCollection 2017 Jun.
- Individual participant dataSharing planned: Undecided
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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.
Stefan M Pasiakos, Ph.D. principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine-enriched nutritional supplement in people with Muscle Loss and Muscle Anabolism, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
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 3 inclusion and 8 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 21 Jul 2017. 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 United States. 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?
Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation (time frame: 90 min exercise bout (exercise) and 180 min of recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714479, which also lists 3 linked publications.
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 21 Jul 2017.