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CompletedNCT04910724Updated Jan 21, 2026

Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise

An interventional study of Energy Deficit in Energy Supply; Deficiency, Severe, Energy Supply; Deficiency and Stress, Physiological, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This randomized, parallel study will examine the effects of energy balance and varying magnitudes of energy deficit on 1) the protein kinetic responses to consuming high quality protein and 2) carbohydrate oxidation during steady-state exercise. Healthy adults, representative of active duty military personnel, will complete a 2 d energy balance phase followed by a randomly assigned, 5 d energy deficit phase (n=15 per group; 20%, 40% and 60% energy deficit). At the end of each energy phase the effects of energy balance and energy deficit severity on resting postabsorptive (fasting) and postprandial (after consuming \~34 g protein) muscle protein synthesis (MPS) and whole-body protein synthesis, breakdown, and balance (synthesis - breakdown) will be determined. On the next day, the effects energy balance and energy deficit severity on carbohydrate oxidation during steady-state exercise will be determined. Primary study procedures include anthropometric and body composition measures, resting metabolic rate measures, aerobic exercise, tightly controlled diet and exercise interventions, repeated blood sampling, stable isotope infusion, stable isotope ingestion, and percutaneous muscle biopsies. The following hypotheses will be tested: 1) Δ (postprandial - postabsorptive) MPS and Δ whole-body protein balance at rest will progressively decrease as magnitude of energy deficit increases and 2) exogenous carbohydrate oxidation will be higher and endogenous carbohydrate oxidation will be lower during steady-state exercise as magnitude of energy deficit increases.

02

Conditions studied

  • Energy Supply; Deficiency, Severe
  • Energy Supply; Deficiency
  • Stress, Physiological
03

In context

Lead sponsor

United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men and women aged 18 - 35 years
  • Body mass index \< 30.0 kg/m2
  • Weight stable for the past 2 months (± \~2.27 kg)
  • Healthy without evidence of chronic illness or musculoskeletal injury as determined by the US Army Research Institute of Environmental Medicine Office of Medical Support and Oversight (OMSO) or home duty station medical support
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week defined by self-report 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 muscle biopsy and at least 5 days after completing the last muscle biopsy
  • Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements during the intervention periods of the study
  • Supervisor approval for federal civilian employees and non-Natick Soldier Systems Center Human Research Volunteer (HRV) active duty military personnel
  • 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

Exclusion Criteria:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Significantly abnormal blood clotting as determined by OMSO or home duty station medical support
  • History of complications with lidocaine
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support
  • Blood donation within 8-wk of beginning the study
  • Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing)
  • Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
  • Unwilling or unable to adhere to study physical restrictions
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    20% Energy Deficit

    Energy Deficit equal to 20% total daily energy requirements.

    Other: Energy Deficit

  • Experimental
    40% Energy Deficit

    Energy Deficit equal to 40% total daily energy requirements.

    Other: Energy Deficit

  • Experimental
    60% Energy Deficit

    Energy Deficit equal to 60% total daily energy requirements.

    Other: Energy Deficit

Interventions

  • OtherEnergy Deficit

    A combination of individualized exercise performed on a cycle ergometer and individualized dietary prescriptions will be used to achieve energy balance or the assigned energy deficits throughout the controlled feeding and testing periods

06

What researchers measure

Primary outcomes

  1. Whole-body protein balance

    Determined using L-\[1-13C\]-leucine stable isotope.

    Time frame: 2 days

  2. Muscle Protein Synthesis

    Determined using L-\[ring-2H5\]-phenylalanine stable isotope.

    Time frame: 2 days

  3. Carbohydrate Oxidation during Steady-state Exercise

    Determined using U-13C-glucose stable isotope.

    Time frame: 2 days

07

Study locations

1 site
  • US Army Research Institute of Environmental Medicine
    Natick, Massachusetts 01760, United States
08

References and documents

Study documents

  • Informed consent form · May 8, 2023

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04910724
Lead sponsor
United States Army Research Institute of Environmental Medicine
Responsible party
Sponsor
First posted
Jun 2, 2021
Start date
Aug 16, 2022
Primary completion
Mar 7, 2024
Completion
Mar 7, 2024
Last update
Jan 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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