- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621175
Effects of Essential Amino Acid-enriched Whey and Carbohydrate Co-ingestion on Protein Kinetics
January 22, 2025 updated by: United States Army Research Institute of Environmental Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- US Army Research Institute of Environmental Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EAA+W & Carbohydrate: Balance (BAL) first, then Deficit (DEF)
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).
|
Essential amino acid plus whey beverage with added carbohydrate
|
|
Active Comparator: EAA+W & Carbohydrate: DEF first, then BAL
Participants will consume an essential amino acid plus whey beverage with added Carbohydrate during energy deficit first, then again during energy balance.
|
Essential amino acid plus whey beverage with added carbohydrate
|
|
Active Comparator: EAA+W & EAA: BAL first, then DEF
Participants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy balance first, then again during energy deficit.
|
Essential amino acid plus whey beverage with added essential amino acid
|
|
Active Comparator: EAA+W & EAA: DEF first, then BAL
Participants will consume an essential amino acid (EAA) plus whey beverage with added EAA during energy deficit first, then again during energy balance.
|
Essential amino acid plus whey beverage with added essential amino acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole-body Protein Balance
Time Frame: approximately 5.75 hours
|
Whole-body net balance will be determined using stable-isotope methodologies
|
approximately 5.75 hours
|
|
Whole-body Protein Synthesis
Time Frame: approximately 5.75 hours
|
Whole-body protein synthesis will be determined using stable-isotope methodologies
|
approximately 5.75 hours
|
|
Whole-body Protein Breakdown
Time Frame: approximately 5.75 hours
|
Whole-body protein breakdown will be determined using stable-isotope methodologies
|
approximately 5.75 hours
|
|
Muscle Protein Synthesis
Time Frame: approximately 5.75 hours
|
Muscle protein synthesis will be determined using stable-isotope methodologies
|
approximately 5.75 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jess A Gwin, PhD, US Army Research Institute of Environmental Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Actual)
August 23, 2022
Study Completion (Actual)
August 23, 2022
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (Actual)
November 9, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 22, 2025
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20-14HC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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