Muscle LossPhase 1/2NCT01366924
Essential Amino Acids Supplementation and Muscle Protein Synthesis
A Phase 1/2 study testing Essential Amino Acids and Endurance exercise in people with Muscle Loss and Muscle Anabolism, run by United States Army Research Institute of Environmental Medicine at 2 sites in United States.
Trial summary
The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss, Muscle Anabolism
- What is being tested?
- Essential Amino Acids and Endurance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Jul 2010
- Phase
- Phase 1/2
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 - 35 years
- Weight stable
- Recreationally active with VO2max of 40 - 50 ml/kg/min
- Refrain from taking any NSAIDS or any aspirin-containing medications
- Supervisor approval if a federal employee
Who cannot join
- Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
- Allergies to foods or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
- Abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism or other substance abuse that compromises exercise capacity
- Musculoskeletal injuries that compromise the ability to exercise
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts University
Boston, Massachusetts, 02111
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: The Effect of Amino Acid Supplementation on Skeletal Muscle Protein Turnover Following Endurance Exercise
The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance. Dietary interventions may help preserve lean body mass and facilitate recovery from periods of intense physical demand. For example, dietary strategies that increase amino acid availability have been shown to stimulate protein synthesis in skeletal muscle following resistance exercise. Because military tasks also incorporate endurance exercise components, studies regarding the effects of increasing dietary amino acids following endurance exercise are warranted. The objectives of this study are to characterize the effect of endurance exercise on protein synthesis and breakdown as well as the ability of an essential amino acid supplement to influence skeletal muscle protein metabolism and its cellular and molecular regulation following endurance exercise.
- Conditions
- Muscle Loss, Muscle Anabolism
- Being tested
- Essential Amino Acids, Endurance exercise
- Keywords
- protein turnover, whole body protein turnover, essential amino acids, leucine
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino AcidsDietary supplement
10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
Endurance exerciseOther
60 minute endurance exercise session
| Study group | Role | What they receive |
|---|---|---|
| Muscle protein turnover and intracellular signaling at rest | No intervention | Muscle protein turnover and intracellular signaling are measured at rest for comparison to post-exercise muscle metabolism. |
| Muscle metabolism after endurance exercise | Active comparator | Post-exercise muscle protein metabolism was measured to determine if endurance exercise affects muscle metabolism compared to rest. Receives: Dietary Supplement: Essential Amino Acids; Other: Endurance exercise |
| Muscle Metabolism after endurance exercise | Experimental | Muscle metabolism response to endurance exercise with essential amino acid supplementation Receives: Dietary Supplement: Essential Amino Acids |
| Muscle anabolism after endurance exercise | Experimental | Muscle anabolism after endurance exercise with essential amino acid supplementation. Receives: Dietary Supplement: Essential Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle protein synthesis after exercise or exercise with amino acid supplementation.
Measured: An average change over a 210 minute recovery period from a 60 minute endurance exercise session
Secondary outcomes (1)
Change in intracellular signaling after exercise or exercise with amino acid supplementation.
Measured: At 30 minutes and 210 minutes after a 60 minute endurance exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2007
- Primary completionJul 2010
- Study completionJul 2010
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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Tufts University
- Investigators
- Stefan M Pasiakos, Ph.D., Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366924
- Sponsor's protocol ID
- H06-04
- Other IDs
- 7906 Tufts
- Status last verified
- Jun 2011
- First submitted
- 1 Jun 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pasiakos SM, McClung HL, McClung JP, Margolis LM, Andersen NE, Cloutier GJ, Pikosky MA, Rood JC, Fielding RA, Young AJ. Leucine-enriched essential amino acid supplementation during moderate steady state exercise enhances postexercise muscle protein synthesis. Am J Clin Nutr. 2011 Sep;94(3):809-18. doi: 10.3945/ajcn.111.017061. Epub 2011 Jul 20.
PubMed 21775557Pasiakos SM, McClung HL, McClung JP, Urso ML, Pikosky MA, Cloutier GJ, Fielding RA, Young AJ. Molecular responses to moderate endurance exercise in skeletal muscle. Int J Sport Nutr Exerc Metab. 2010 Aug;20(4):282-90. doi: 10.1123/ijsnem.20.4.282.
PubMed 20739716Scofield DE, McClung HL, McClung JP, Kraemer WJ, Rarick KR, Pierce JR, Cloutier GJ, Fielding RA, Matheny RW Jr, Young AJ, Nindl BC. A novel, noninvasive transdermal fluid sampling methodology: IGF-I measurement following exercise. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1326-32. doi: 10.1152/ajpregu.00313.2010. Epub 2011 Mar 9.
PubMed 21389329
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
- The Effect of Amino Acid Supplementation on Skeletal Muscle Protein Turnover Following Endurance Exercise
- ClinicalTrials.gov ID
- NCT01366924
- Acronym / sponsor ID
- H06-04
- Conditions
- Muscle Loss, Muscle Anabolism
- Keywords
- protein turnover, whole body protein turnover, essential amino acids, leucine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Tufts University
- Study start
- May 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Jun 2011 (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.
The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance. Dietary interventions may help preserve lean body mass and facilitate recovery from periods of intense physical demand. For example, dietary strategies that increase amino acid availability have been shown to stimulate protein synthesis in skeletal muscle following resistance exercise. Because military tasks also incorporate endurance exercise components, studies regarding the effects of increasing dietary amino acids following endurance exercise are warranted. The objectives of this study are to characterize the effect of endurance exercise on protein synthesis and breakdown as well as the ability of an essential amino acid supplement to influence skeletal muscle protein metabolism and its cellular and molecular regulation following endurance exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Muscle protein turnover and intracellular signaling at rest | No intervention | –Muscle protein turnover and intracellular signaling are measured at rest for comparison to post-exercise muscle metabolism. |
| Muscle metabolism after endurance exercise | Active comparator | Dietary Supplement: Essential Amino Acids, Other: Endurance exercisePost-exercise muscle protein metabolism was measured to determine if endurance exercise affects muscle metabolism compared to rest. |
| Muscle Metabolism after endurance exercise | Experimental | Dietary Supplement: Essential Amino AcidsMuscle metabolism response to endurance exercise with essential amino acid supplementation |
| Muscle anabolism after endurance exercise | Experimental | Dietary Supplement: Essential Amino AcidsMuscle anabolism after endurance exercise with essential amino acid supplementation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged 18 - 35 years
- Weight stable
- Recreationally active with VO2max of 40 - 50 ml/kg/min
- Refrain from taking any NSAIDS or any aspirin-containing medications
- Supervisor approval if a federal employee
Key exclusion criteria (6 listed)
- Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
- Allergies to foods or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
- Abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism or other substance abuse that compromises exercise capacity
- Musculoskeletal injuries that compromise the ability to exercise
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 |
|---|---|---|
| Essential Amino Acids10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials | Dietary supplement | Muscle Metabolism after endurance exercise, Muscle anabolism after endurance exercise, Muscle metabolism after endurance exercise |
| Endurance exercise60 minute endurance exercise session | Other | Muscle metabolism after endurance exercise |
Primary outcome
Change in muscle protein synthesis after exercise or exercise with amino acid supplementation.
Time frame: An average change over a 210 minute recovery period from a 60 minute endurance exercise session
1 secondary outcome
Change in intracellular signaling after exercise or exercise with amino acid supplementation.
Time frame: At 30 minutes and 210 minutes after a 60 minute endurance exercise session
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 21775557Pasiakos SM, McClung HL, McClung JP, Margolis LM, Andersen NE, Cloutier GJ, Pikosky MA, Rood JC, Fielding RA, Young AJ. Leucine-enriched essential amino acid supplementation during moderate steady state exercise enhances postexercise muscle protein synthesis. Am J Clin Nutr. 2011 Sep;94(3):809-18. doi: 10.3945/ajcn.111.017061. Epub 2011 Jul 20.
- Results publication: PubMed 20739716Pasiakos SM, McClung HL, McClung JP, Urso ML, Pikosky MA, Cloutier GJ, Fielding RA, Young AJ. Molecular responses to moderate endurance exercise in skeletal muscle. Int J Sport Nutr Exerc Metab. 2010 Aug;20(4):282-90. doi: 10.1123/ijsnem.20.4.282.
- Results publication: PubMed 21389329Scofield DE, McClung HL, McClung JP, Kraemer WJ, Rarick KR, Pierce JR, Cloutier GJ, Fielding RA, Matheny RW Jr, Young AJ, Nindl BC. A novel, noninvasive transdermal fluid sampling methodology: IGF-I measurement following exercise. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1326-32. doi: 10.1152/ajpregu.00313.2010. Epub 2011 Mar 9.
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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
US Army Research Institute of Environmental Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Essential Amino Acids and Endurance exercise in people with Muscle Loss and Muscle Anabolism, run by United States Army Research Institute of Environmental Medicine at 2 sites 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 5 inclusion and 6 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 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 after exercise or exercise with amino acid supplementation. (time frame: An average change over a 210 minute recovery period from a 60 minute endurance exercise session). 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 NCT01366924, 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.