Recruiting

Whey Protein

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT07069426

Conditions

Muscle Disuse

Muscle Disuse Atrophy

Eligibility Criteria

Sex: All

Age: 17 - 39

Healthy Volunteers: Accepted

Interventions

20 grams protein

40 grams protein

Study Details

Brief summary:

Individuals who sustain musculoskeletal injuries (MSKI) can experience a rapid loss of muscle mass due to declines in muscle loading and activation that occur post-injury (i.e., disuse atrophy). Loss of muscle under these conditions is attributed to a persistent negative net muscle protein balance (muscle protein synthesis \[MPS\] < muscle protein breakdown) that results, in part, from declines in postprandial MPS (i.e., anabolic resistance). Nutritional interventions that enhance postprandial MPS may be used to overcome disuse-induced anabolic resistance and preserve muscle mass to accelerate recovery and improve recovery outcomes. While supplemental protein has been explored as a potential countermeasure to disuse-induce anabolic resistance, the observed efficacy of such interventions has been mixed. Equivocal findings across studies may be attributed, in part, to an insufficient understanding of what constitutes an effective protein-based intervention. Importantly, no study to date has determined an optimal protein dose for overcoming disuse-induce anabolic resistance, or if there is a threshold for maximally stimulating postprandial MPS under disuse conditions. Therefore, the objective of this work is to determine rates of MPS at rest and in response to standard (20 g) or high (40 g) doses of whey protein during knee immobilization (DISUSE) compared with standard activity (ACTIVE)

Conditions

Muscle Disuse

Muscle Disuse Atrophy

Study ID

NCT07069426

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 39

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women aged 18-39 years (17-39 years if military personnel)
  • Body mass index (BMI) between 18.5-32 kg/m2
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week.
  • Willing to refrain from alcohol, smoking, smokeless nicotine products (includes e-cigarettes, vaping, chewing tobacco), and dietary supplements (i.e., vitamin D, probiotics) 24 hours before and during immobilization and final testing day.
  • Willing to only consume caffeine products provided by study staff during the study.
  • Supervisor approval for federal civilian employees and non-SRV active-duty military personnel stationed at NSSC.
  • Biological females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or on continuous hormonal contraception (i.e., IUD or oral contraceptives without placebo).

Exclusion Criteria:

  • Musculoskeletal injuries that may interfere with the safe use of crutches.
  • Personal or family history of thrombosis, or prior diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders, neuromuscular disorders, lower-limb amputation, or muscle/bone wasting disorders (e.g., diabetes, cardiovascular disease, Crohn's disease, etc.).
  • Taking medication that affects macronutrient utilization (i.e., statins, corticosteroids, weight loss medications such as Ozempic, etc.).
  • Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS).
  • Allergy to lidocaine (or similar local anesthetic).
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or HMS.
  • 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 and/or food allergies.
  • Unwilling or unable to adhere to study physical restrictions (i.e., no structured physical activity or recreational activity beyond activities of daily living) 24 hours before and during immobilization, and the final testing day.
  • Unwilling or unable to keep the knee brace on and walk with crutches during the immobilization phase.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Standard Protein Dose

Participants will consume 20 g of whey protein after 5 days of muscle disuse

active comparator: High Protein Dose

Participants will consume 40 g of whey protein after 5 days of muscle disuse

Interventions

20 grams protein

20 grams of whey protein provided as beverage

40 grams protein

40 grams of whey protein provided as beverage

Primary outcome measure

  • Rates of postabsorptive and postprandial muscle protein synthesis assessed using 2H5-Phenylalanine stable isotope methodologies. [ Time Frame: After 5 days of muscle disuse ]

Central Contacts and Locations

Central contacts

Locations

US Army Research Institute of Environmental Medicine

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Principal Investigator:

Emily E Howard, PhD

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • muscle protein synthesis
  • muscle disuse
  • muscle disuse atrophy
  • immobilization
  • anabolic resistance
  • dose-response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2025-09-11.