Whole-body Protein BalanceNCT04004715
Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit
A study testing Essential Amino Acid Enriched Whey Protein, Whey Protein and Military Ration Entree in people with Whole-body Protein Balance and Muscle Protein Synthesis, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
The optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Whole-body Protein Balance, Muscle Protein Synthesis
- What is being tested?
- Essential Amino Acid Enriched Whey Protein, Whey Protein and Military Ration Entree
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 13 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 - 35 years
- Body mass index < 30.0 kg/m2
- Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
- Resistance exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 mo
- Refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine, and dietary supplement use throughout the entire study period
- Supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center
Who cannot join
- Musculoskeletal injuries that compromise exercise capability as determined by the USARIEM or home duty station Office of Medical Support and Oversight (OMSO)
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Abnormal PT/PTT test or problems with blood clotting
- History of complications with lidocaine
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Blood donation within 8-wk of beginning the study
- Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing)
- Unwillingness or inability to consume study diets or foods provided
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: Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Negative Energy Balance
The optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.
Read the detailed description
Ten resistance-trained adults will complete this ~55-d randomized, cross-over study. Participants will participate in three, non-consecutive 5-d controlled energy deficit periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying EAA-containing protein formats will be determined the morning after completing the 5-d energy deficit.
- Being tested
- Essential Amino Acid Enriched Whey Protein, Whey Protein, Military Ration Entree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino Acid Enriched Whey ProteinDietary supplement
protein powder formulation that includes whey and free-form essential amino acids
Whey ProteinDietary supplement
commercially available whey protein isolate
Military Ration EntreeDietary supplement
chili and beans entree; current meal component of the meals ready to eat rations
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acid Enriched Whey Protein | Experimental | protein powder formulation that includes whey and free-form essential amino acids Receives: Dietary Supplement: Essential Amino Acid Enriched Whey Protein |
| Whey Protein | Active comparator | commercially available whey protein isolate Receives: Dietary Supplement: Whey Protein |
| Military Ration Entree | Active comparator | chili and beans entree; current meal component of the meals ready to eat rations Receives: Dietary Supplement: Military Ration Entree |
What is being measured
The primary outcome is the main question the study is designed to answer.
How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise
Assessed using stable isotope infusions of phenylalanine.
Measured: ~4.5 hour measure of muscle protein synthesis
Secondary outcomes (1)
How well participants suppress the degradation of body proteins while stimulating the growth of new proteins after ingesting varying forms of essential amino acid-containing proteins after exercise.
Assessed using stable isotope infusions of tyrosine.
Measured: ~4.5 hour measure of whole-body protein balance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start25 Apr 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whole-body Protein BalanceStudies 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
- Crossover
- Model description
- Randomized, partially-blind, cross-over controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Stefan Pasiakos, United States Army Research Institute of Environmental Medicine
- Investigators
- Stefan Pasiakos, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004715
- Sponsor's protocol ID
- 19-06HC
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gwin JA, Church DD, Hatch-McChesney A, Allen JT, Wilson MA, Varanoske AN, Carrigan CT, Murphy NE, Margolis LM, Carbone JW, Wolfe RR, Ferrando AA, Pasiakos SM. Essential amino acid-enriched whey enhances post-exercise whole-body protein balance during energy deficit more than iso-nitrogenous whey or a mixed-macronutrient meal: a randomized, crossover study. J Int Soc Sports Nutr. 2021 Jan 7;18(1):4. doi: 10.1186/s12970-020-00401-5.
PubMed 33413462
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Negative Energy Balance
- ClinicalTrials.gov ID
- NCT04004715
- Acronym / sponsor ID
- 19-06HC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- University of Arkansas
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- 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 optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.
Detailed description
Ten resistance-trained adults will complete this ~55-d randomized, cross-over study. Participants will participate in three, non-consecutive 5-d controlled energy deficit periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying EAA-containing protein formats will be determined the morning after completing the 5-d energy deficit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, partially-blind, cross-over controlled trial
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acid Enriched Whey Protein | Experimental | Dietary Supplement: Essential Amino Acid Enriched Whey Proteinprotein powder formulation that includes whey and free-form essential amino acids |
| Whey Protein | Active comparator | Dietary Supplement: Whey Proteincommercially available whey protein isolate |
| Military Ration Entree | Active comparator | Dietary Supplement: Military Ration Entreechili and beans entree; current meal component of the meals ready to eat rations |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women aged 18 - 35 years
- Body mass index < 30.0 kg/m2
- Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
- Resistance exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 mo
- Refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
Key exclusion criteria (8 listed)
- Musculoskeletal injuries that compromise exercise capability as determined by the USARIEM or home duty station Office of Medical Support and Oversight (OMSO)
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Abnormal PT/PTT test or problems with blood clotting
- History of complications with lidocaine
- Present condition of alcoholism, 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 |
|---|---|---|
| Essential Amino Acid Enriched Whey Proteinprotein powder formulation that includes whey and free-form essential amino acids | Dietary supplement | Essential Amino Acid Enriched Whey Protein |
| Whey Proteincommercially available whey protein isolate | Dietary supplement | Whey Protein |
| Military Ration Entreechili and beans entree; current meal component of the meals ready to eat rations | Dietary supplement | Military Ration Entree |
Primary outcome
How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise
Time frame: ~4.5 hour measure of muscle protein synthesis
Assessed using stable isotope infusions of phenylalanine.
1 secondary outcome
How well participants suppress the degradation of body proteins while stimulating the growth of new proteins after ingesting varying forms of essential amino acid-containing proteins after exercise.
Time frame: ~4.5 hour measure of whole-body protein balance
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 12 Mar 2020.
- Derived from this study: PubMed 33413462Gwin JA, Church DD, Hatch-McChesney A, Allen JT, Wilson MA, Varanoske AN, Carrigan CT, Murphy NE, Margolis LM, Carbone JW, Wolfe RR, Ferrando AA, Pasiakos SM. Essential amino acid-enriched whey enhances post-exercise whole-body protein balance during energy deficit more than iso-nitrogenous whey or a mixed-macronutrient meal: a randomized, crossover study. J Int Soc Sports Nutr. 2021 Jan 7;18(1):4. doi: 10.1186/s12970-020-00401-5.
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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 Pasiakos, PhD 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 Essential Amino Acid Enriched Whey Protein, Whey Protein and Military Ration Entree in people with Whole-body Protein Balance and Muscle Protein Synthesis, 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 7 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 12 Mar 2020. 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. 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?
How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise (time frame: ~4.5 hour measure of muscle protein synthesis). 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 NCT04004715, which also lists 1 linked publication.
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 12 Mar 2020.