Energy DeficitNCT04621175
Effects of Essential Amino Acid-enriched Whey and Carbohydrate Co-ingestion on Protein Kinetics
A study testing EAA+W & Carbohydrate and EAA+W & EAA in people with Energy Deficit, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
Previous work conducted by the Investigators demonstrates that an essential amino acid(EAA)-enriched whey protein combination format is an efficient EAA/protein format to support enhanced whole-body protein balance and sustain muscle protein synthesis compared to isonitrogenous amounts of whey alone or a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Deficit
- What is being tested?
- EAA+W & Carbohydrate and EAA+W & EAA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 23 Aug 2022
- 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
- Body mass index < 30.0 kg/m2
- Weight stable in the past 2 months (± 2.27 kg)
- 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
- Functional exercise (i.e., step ups, box jumps, body mass movements) and/or aerobic exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 months
- Willing to refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before the first ~8.5 hour laboratory day and at least 5 days after completing the last ~8.5 hour laboratory day
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes), vaping, chewing tobacco, caffeine, and dietary supplements after the completing the baseline period until the end of the study
- Must obtain supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center
- Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
Who cannot join
- 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 as assessed by OMSO
- Participation in 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 due to personal preference, dietary restrictions, and/or food allergies
- Unwillingness to adhere to study physical restrictions
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: Determining Optimal Energy Substrate to Enhance Postprandial Protein Kinetic Responses to Essential Amino Acid-enriched Whey During Energy Deficit
Previous work conducted by the Investigators demonstrates that an essential amino acid(EAA)-enriched whey protein combination format is an efficient EAA/protein format to support enhanced whole-body protein balance and sustain muscle protein synthesis compared to isonitrogenous amounts of whey alone or a mixed-macronutrient meal. However, additional work is needed to optimize the formulation to ensure the best possible muscle and whole-body anabolic responses are achieved. This includes addressing the potential value of adding non-EAA/protein components to support energy demands. Providing additional non-protein energy to an EAA-enriched whey protein formulation may reduce the proportion of exogenous amino acids directed towards energy production thereby preserving its use for muscle protein synthesis. However, whether suppressing exogenous amino acid oxidation by providing additional carbohydrate allows for a greater muscle protein synthetic stimulus during moderate energy deficit (- 30% total energy requirements) is unknown. Therefore, this study will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design.
Read the detailed description
In this study the Investigators will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design. Thirty healthy, functional and aerobic exercise trained adults will complete two, 5-d controlled feeding phases, one maintaining energy balance and one inducing energy deficit in random order and separated by at least a 7d washout period. The difference in post-exercise (whole-body exercise model) muscle protein synthesis and whole-body protein turnover between the study treatments will be determined the day after each 5-d controlled feeding phase. This design will test the following hypotheses: 1) The magnitude of post-exercise anabolic response to EAA-enriched whey protein plus carbohydrate are enhanced compared to EAA-enriched whey protein plus additional EAA during energy deficit; 2) Regardless of protein treatment, the magnitude of anabolic response will be reduced during energy deficit compared to energy balance.
- Conditions
- Energy Deficit
- Being tested
- EAA+W & Carbohydrate, EAA+W & EAA
- Keywords
- whole-body protein turnover, muscle protein synthesis, protein kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAA+W & CarbohydrateDietary supplement
Essential amino acid plus whey beverage with added carbohydrate
EAA+W & EAADietary supplement
Essential amino acid plus whey beverage with added essential amino acid
| Study group | Role | What they receive |
|---|---|---|
| EAA+W & Carbohydrate: Balance (BAL) first, then Deficit (DEF) | Active comparator | Participants will consume an essential amino acid plus whey (EAA+W) beverage with added Carbohydrate during energy balance (BAL) first, then again during energy deficit (DEF). Receives: Dietary Supplement: EAA+W & Carbohydrate |
| EAA+W & Carbohydrate: DEF first, then BAL | Active comparator | Participants will consume an essential amino acid plus whey beverage with added Carbohydrate during energy deficit first, then again during energy balance. Receives: Dietary Supplement: EAA+W & Carbohydrate |
| EAA+W & EAA: BAL first, then DEF | Active comparator | Participants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy balance first, then again during energy deficit. Receives: Dietary Supplement: EAA+W & EAA |
| EAA+W & EAA: DEF first, then BAL | Active comparator | Participants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy deficit first, then again during energy balance. Receives: Dietary Supplement: EAA+W & EAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body Protein Balance
Whole-body net balance will be determined using stable-isotope methodologies
Measured: approximately 5.75 hours
Whole-body Protein Synthesis
Whole-body protein synthesis will be determined using stable-isotope methodologies
Measured: approximately 5.75 hours
Whole-body Protein Breakdown
Whole-body protein breakdown will be determined using stable-isotope methodologies
Measured: approximately 5.75 hours
Muscle Protein Synthesis
Muscle protein synthesis will be determined using stable-isotope methodologies
Measured: approximately 5.75 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start9 Sep 2020
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Energy DeficitStudies 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
- Model description
- randomized, cross-sectional, longitudinal study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- University of Arkansas, Eastern Michigan University
- Responsible party
- Sponsor
- Investigators
- Jess A Gwin, PhD, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621175
- Sponsor's protocol ID
- 20-14HC
- Status last verified
- Oct 2022
- First submitted
- 24 Aug 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gwin JA, Robillard JT, Murphy NE, Carrigan CT, Wilson MA, Varanoske AN, Church DD, Ferrando AA, Pasiakos SM, Margolis LM. Elevated miR-194-5p Expression during Short-Term Energy Deficit Attenuates Postexercise Muscle Protein Synthesis by Inhibiting Anabolic Signaling. J Nutr. 2026 Apr;156(4):101380. doi: 10.1016/j.tjnut.2026.101380. Epub 2026 Jan 27.
PubMed 41611130Gwin JA, Church DD, Allen JT, Wilson MA, Carrigan CT, Murphy NE, Varanoske AN, Margolis LM, Wolfe RR, Ferrando AA, Pasiakos SM. Consuming Whey Protein with Added Essential Amino Acids, Not Carbohydrate, Maintains Postexercise Anabolism While Underfed. Med Sci Sports Exerc. 2025 Jan 1;57(1):70-80. doi: 10.1249/MSS.0000000000003541. Epub 2024 Aug 23.
PubMed 39160756
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Energy Substrate to Enhance Postprandial Protein Kinetic Responses to Essential Amino Acid-enriched Whey During Energy Deficit
- ClinicalTrials.gov ID
- NCT04621175
- Acronym / sponsor ID
- 20-14HC
- Conditions
- Energy Deficit
- Keywords
- whole-body protein turnover, muscle protein synthesis, protein kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- University of Arkansas, Eastern Michigan University
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 9 Nov 2020 (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.
Previous work conducted by the Investigators demonstrates that an essential amino acid(EAA)-enriched whey protein combination format is an efficient EAA/protein format to support enhanced whole-body protein balance and sustain muscle protein synthesis compared to isonitrogenous amounts of whey alone or a mixed-macronutrient meal. However, additional work is needed to optimize the formulation to ensure the best possible muscle and whole-body anabolic responses are achieved. This includes addressing the potential value of adding non-EAA/protein components to support energy demands. Providing additional non-protein energy to an EAA-enriched whey protein formulation may reduce the proportion of exogenous amino acids directed towards energy production thereby preserving its use for muscle protein synthesis. However, whether suppressing exogenous amino acid oxidation by providing additional carbohydrate allows for a greater muscle protein synthetic stimulus during moderate energy deficit (- 30% total energy requirements) is unknown. Therefore, this study will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design.
Detailed description
In this study the Investigators will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design. Thirty healthy, functional and aerobic exercise trained adults will complete two, 5-d controlled feeding phases, one maintaining energy balance and one inducing energy deficit in random order and separated by at least a 7d washout period. The difference in post-exercise (whole-body exercise model) muscle protein synthesis and whole-body protein turnover between the study treatments will be determined the day after each 5-d controlled feeding phase. This design will test the following hypotheses: 1) The magnitude of post-exercise anabolic response to EAA-enriched whey protein plus carbohydrate are enhanced compared to EAA-enriched whey protein plus additional EAA during energy deficit; 2) Regardless of protein treatment, the magnitude of anabolic response will be reduced during energy deficit compared to energy balance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- randomized, cross-sectional, longitudinal study
| Arm | Type | Receives |
|---|---|---|
| EAA+W & Carbohydrate: Balance (BAL) first, then Deficit (DEF) | Active comparator | Dietary Supplement: EAA+W & CarbohydrateParticipants will consume an essential amino acid plus whey (EAA+W) beverage with added Carbohydrate during energy balance (BAL) first, then again during energy deficit (DEF). |
| EAA+W & Carbohydrate: DEF first, then BAL | Active comparator | Dietary Supplement: EAA+W & CarbohydrateParticipants will consume an essential amino acid plus whey beverage with added Carbohydrate during energy deficit first, then again during energy balance. |
| EAA+W & EAA: BAL first, then DEF | Active comparator | Dietary Supplement: EAA+W & EAAParticipants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy balance first, then again during energy deficit. |
| EAA+W & EAA: DEF first, then BAL | Active comparator | Dietary Supplement: EAA+W & EAAParticipants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy deficit first, then again during energy balance. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body mass index < 30.0 kg/m2
- Weight stable in the past 2 months (± 2.27 kg)
- 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
- Functional exercise (i.e., step ups, box jumps, body mass movements) and/or aerobic exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 months
- Willing to refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before the first ~8.5 hour laboratory day and at least 5 days after completing the last ~8.5 hour laboratory day
Key exclusion criteria (8 listed)
- 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 as assessed by OMSO
- Participation in blood donation within 8-wk of beginning the study
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 |
|---|---|---|
| EAA+W & CarbohydrateEssential amino acid plus whey beverage with added carbohydrate | Dietary supplement | EAA+W & Carbohydrate: Balance (BAL) first, then Deficit (DEF), EAA+W & Carbohydrate: DEF first, then BAL |
| EAA+W & EAAEssential amino acid plus whey beverage with added essential amino acid | Dietary supplement | EAA+W & EAA: BAL first, then DEF, EAA+W & EAA: DEF first, then BAL |
Primary outcome
Whole-body Protein Balance
Time frame: approximately 5.75 hours
Whole-body net balance will be determined using stable-isotope methodologies
Whole-body Protein Synthesis
Time frame: approximately 5.75 hours
Whole-body protein synthesis will be determined using stable-isotope methodologies
Whole-body Protein Breakdown
Time frame: approximately 5.75 hours
Whole-body protein breakdown will be determined using stable-isotope methodologies
Muscle Protein Synthesis
Time frame: approximately 5.75 hours
Muscle protein synthesis will be determined using stable-isotope methodologies
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 27 Jan 2025.
- Derived from this study: PubMed 41611130Gwin JA, Robillard JT, Murphy NE, Carrigan CT, Wilson MA, Varanoske AN, Church DD, Ferrando AA, Pasiakos SM, Margolis LM. Elevated miR-194-5p Expression during Short-Term Energy Deficit Attenuates Postexercise Muscle Protein Synthesis by Inhibiting Anabolic Signaling. J Nutr. 2026 Apr;156(4):101380. doi: 10.1016/j.tjnut.2026.101380. Epub 2026 Jan 27.
- Derived from this study: PubMed 39160756Gwin JA, Church DD, Allen JT, Wilson MA, Carrigan CT, Murphy NE, Varanoske AN, Margolis LM, Wolfe RR, Ferrando AA, Pasiakos SM. Consuming Whey Protein with Added Essential Amino Acids, Not Carbohydrate, Maintains Postexercise Anabolism While Underfed. Med Sci Sports Exerc. 2025 Jan 1;57(1):70-80. doi: 10.1249/MSS.0000000000003541. Epub 2024 Aug 23.
- Individual participant dataSharing planned: No
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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.
Jess A Gwin, PhD principal investigator
US 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 EAA+W & Carbohydrate and EAA+W & EAA in people with Energy Deficit, 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 8 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 27 Jan 2025. 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?
Whole-body Protein Balance (time frame: approximately 5.75 hours). The study lists 4 primary outcomes in all. 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 NCT04621175, which also lists 2 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 27 Jan 2025.