An interventional study of 20 grams protein and 40 grams protein in Muscle Disuse and Muscle Disuse Atrophy, sponsored by United States Army Research Institute of Environmental Medicine. Recruiting at 1 site in United States. Open to participants aged 17 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Basic science
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)
Healthy, recreationally active men and women will complete this randomized, double-blind, parallel study. Muscle disuse will be implemented for five days using a unilateral leg immobilization model with one leg assigned to immobilization (DISUSE) and the contralateral leg used as a control (ACTIVE). Immobilization will be implemented with a rigid knee brace fixed at \~60° of flexion and participants will ambulate using crutches. Diets will be standardized during the immobilization phase. Participants will complete a protein feeding study at the end of immobilization consisting of primed, continuous stable isotope infusions, serial blood draws, and muscle biopsies. MPS will be assessed in both the DISUSE and ACTIVE legs in response to standard (20 g) or high (40 g) doses of whey protein. Findings from this work will directly inform the development of targeted nutritional countermeasures for overcoming disuse-induced anabolic resistance and preserving muscle mass after MSKI to optimize physical performance recovery.
56 studies on the registry are indexed under Muscular Disorders, Atrophic; 13 are open to participants now.
This study's planned enrollment of 28 is above the median of 24 across 49 interventional studies indexed under Muscular Disorders, Atrophic.
Browse Muscular Disorders, Atrophic studies →United States Army Research Institute of Environmental Medicine is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will consume 20 g of whey protein after 5 days of muscle disuse
Dietary Supplement: 20 grams protein
Participants will consume 40 g of whey protein after 5 days of muscle disuse
Dietary Supplement: 40 grams protein
20 grams of whey protein provided as beverage
40 grams of whey protein provided as beverage
Rates of postabsorptive and postprandial muscle protein synthesis assessed using 2H5-Phenylalanine stable isotope methodologies.
Postabsorptive and postprandial muscle protein synthesis in response to 20 or 40 g of whey protein determined using 2H5-Phenylalanine stable isotope methodologies and expressed as fractional synthetic rate (FSR).
Time frame: After 5 days of muscle disuse
Plan to share: No — Individual participant data will not be shared.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 18 interventional studies with no phase under Muscular Disorders, Atrophic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's planned 12 months is below that.
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United States Army Research Institute of Environmental Medicine