NCT04621175

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

January 27, 2025

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

August 24, 2020

Last Update Submit

January 22, 2025

Conditions

Keywords

whole-body protein turnovermuscle protein synthesisprotein kinetics

Outcome Measures

Primary Outcomes (4)

  • Whole-body Protein Balance

    Whole-body net balance will be determined using stable-isotope methodologies

    approximately 5.75 hours

  • Whole-body Protein Synthesis

    Whole-body protein synthesis will be determined using stable-isotope methodologies

    approximately 5.75 hours

  • Whole-body Protein Breakdown

    Whole-body protein breakdown will be determined using stable-isotope methodologies

    approximately 5.75 hours

  • Muscle Protein Synthesis

    Muscle protein synthesis will be determined using stable-isotope methodologies

    approximately 5.75 hours

Study Arms (4)

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).

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.

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.

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.

Dietary Supplement: EAA+W & EAA

Interventions

EAA+W & CarbohydrateDIETARY_SUPPLEMENT

Essential amino acid plus whey beverage with added carbohydrate

EAA+W & Carbohydrate: Balance (BAL) first, then Deficit (DEF)EAA+W & Carbohydrate: DEF first, then BAL
EAA+W & EAADIETARY_SUPPLEMENT

Essential amino acid plus whey beverage with added essential amino acid

EAA+W & EAA: BAL first, then DEFEAA+W & EAA: DEF first, then BAL

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (2)

  • 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 Post-Exercise Muscle Protein Synthesis by Inhibiting Anabolic Signaling. J Nutr. 2026 Jan 27:101380. doi: 10.1016/j.tjnut.2026.101380. Online ahead of print.

  • Gwin 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.

MeSH Terms

Interventions

CarbohydratesExcitatory Amino Acids

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jess A Gwin, PhD

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double (participant and investigator)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: randomized, cross-sectional, longitudinal study
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

November 9, 2020

Study Start

September 9, 2020

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

January 27, 2025

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations