[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07069426":3,"trial-entities:NCT07069426":108,"trial-summary:NCT07069426":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":80,"locations":83,"central_contacts":102,"overall_officials":105,"references":106,"see_also_links":107},"NCT07069426","25-04H","Muscle Response to Different Amounts of Dietary Protein During Leg Immobilization","The Effects of Varying Protein Intakes on Muscle Protein Synthesis During Injury-Mediated Muscle Disuse","RECRUITING","2026-09","2025-09","2025-09-11","2025-09-01","United States Army Research Institute of Environmental Medicine","FED",false,"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\\] \\\u003C 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.",[19,20],"Muscle Disuse","Muscle Disuse Atrophy",[22,23,24,25,26,27],"muscle protein synthesis","muscle disuse","muscle disuse atrophy","immobilization","anabolic resistance","dose-response","INTERVENTIONAL","BASIC_SCIENCE",[31],"NA",{"count":33,"type":34},28,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DIETARY_SUPPLEMENT","20 grams protein","20 grams of whey protein provided as beverage",[41],"Standard Protein Dose",{"type":37,"name":43,"description":44,"armGroupLabels":45},"40 grams protein","40 grams of whey protein provided as beverage",[46],"High Protein Dose",[48],{"measure":49,"description":50,"timeFrame":51},"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).","After 5 days of muscle disuse",[],"ALL","17 Years","39 Years",true,{"inclusion":58,"exclusion":66,"raw_text":79},[59,60,61,62,63,64,65],"Men and women aged 18-39 years (17-39 years if military personnel)","Body mass index (BMI) between 18.5-32 kg\u002Fm2","Routinely participate in aerobic and\u002For 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).",[67,68,69,70,71,72,73,74,75,76,77,78],"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\u002Fbone 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\u002For 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\u002For 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.","Inclusion Criteria:\n\n* Men and women aged 18-39 years (17-39 years if military personnel)\n* Body mass index (BMI) between 18.5-32 kg\u002Fm2\n* Routinely participate in aerobic and\u002For resistance exercise at least 2 days per week.\n* 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.\n* Willing to only consume caffeine products provided by study staff during the study.\n* Supervisor approval for federal civilian employees and non-SRV active-duty military personnel stationed at NSSC.\n* 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).\n\nExclusion Criteria:\n\n* Musculoskeletal injuries that may interfere with the safe use of crutches.\n* Personal or family history of thrombosis, or prior diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).\n* Metabolic or cardiovascular abnormalities, gastrointestinal disorders, neuromuscular disorders, lower-limb amputation, or muscle\u002Fbone wasting disorders (e.g., diabetes, cardiovascular disease, Crohn's disease, etc.).\n* Taking medication that affects macronutrient utilization (i.e., statins, corticosteroids, weight loss medications such as Ozempic, etc.).\n* Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS).\n* Allergy to lidocaine (or similar local anesthetic).\n* Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or HMS.\n* Blood donation within 8-wk of beginning the study.\n* Pregnant, trying to become pregnant, and\u002For breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing).\n* Unwilling or unable to consume study diets or foods provided due to personal preference and\u002For food allergies.\n* 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.\n* Unwilling or unable to keep the knee brace on and walk with crutches during the immobilization phase.",[81,82],"CHILD","ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":99},"US Army Research Institute of Environmental Medicine","Natick","Massachusetts","01760","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Emily Howard, PhD","CONTACT","508-206-2309","emily.e.howard14.civ@health.mil",{"name":97,"role":98},"Emily E Howard, PhD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},42.28343,-71.3495,[103],{"name":97,"role":93,"phone":94,"email":104},"emily.e.howard14.civ@health.mli",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Muscle Atrophy",[],{"nct_id":4,"found":56,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a randomized, double-blind study involving healthy, recreationally active men and women. Approximately 28 participants will be assigned to receive either 20 grams or 40 grams of whey protein.","completed","Dietary Protein for Muscle Disuse","This study is investigating how different amounts of whey protein affect muscle when one leg is immobilized (kept still). Researchers want to see if 20 grams or 40 grams of whey protein can help prevent muscle loss that often happens after injuries, which they call \"disuse atrophy.\" They will measure how well muscles build protein after eating. You may be able to join if you are a healthy man or woman between 17 and 39 years old, exercise regularly, and have a BMI between 18.5 and 32. The study aims to enroll 28 participants, but its current status is unclear.","Muscle protein synthesis will be measured after 5 days of muscle disuse.",100,"You will have one leg immobilized for five days using a brace and crutches. At the end of this period, you will participate in a protein feeding study involving stable isotope infusions, blood draws, and muscle biopsies.","Not stated in the trial record.",[],null]