Muscle Response to Different Amounts of Dietary Protein During Leg Immobilization

Recruiting now · Not applicable

Conditions studied: Muscle Disuse, Muscle Disuse Atrophy

In brief

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)

Key facts

Study ID: NCT07069426
Run by: United States Army Research Institute of Environmental Medicine
People needed: 28
Starts: 2025-09-01
Expected to finish: 2026-09-01
Last updated by the study team: 2025-09-11

Who can join

Age: 17 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

US Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.