[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-loss":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,47,82,115,147,176,202,248,279,303,331,366,387,421],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100526552","testing-liverwatch-a-home-based-remote-monitoring-intervention-for-advanced-liver-disease-100526552",false,"NCT06136221","Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease","Inclusion Criteria:\n\n* English speaking\n* Aged 18 years or older\n* Home-dwelling\n* Diagnosis of cirrhosis- Child Turcotte-Pugh (CTP) B or C or a complication in the past 6 months (CTP B or higher, hepatic encephalopathy, variceal bleeding, fluid overload, liver-related hospitalization, or requiring symptom management with diuretics, non-absorbable disaccharides, rifaximin, nonselective beta blockers)\n* Patient and\u002For caregiver is able and willing to receive SMS text messages\n* Willing and able to wear personal fitness trackers and engage with study staff\n\nExclusion Criteria:\n\n* No access to a smartphone\n* Non-home dwelling\n* On hospice care\n* Model for end stage liver disease (MELD) score ≥30\n* Advanced hepatocellular carcinoma, BCLC C or higher\n* Hospitalization within the last 30 days\n* Deemed not appropriate by treating physician for medical reasons\n* Enrolled in other dietary or physical activity interventions\n* Receiving physical therapy as standard of care","ALL","18 Years",{"count":18,"type":19},110,"ESTIMATED","INTERVENTIONAL",[22],"NA","Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.",[25,26,27,28,29],"Cirrhosis, Liver","End Stage Liver DIsease","Symptoms and Signs","Physical Inactivity","Muscle Loss",[31,32,33],"Telehealth","Remote Symptom Monitoring","Gamification","RECRUITING","2026-05-07",{"date":37,"type":38},"2026-05-11","ACTUAL",{"date":40,"type":38},"2024-05-01",{"date":42,"type":19},"2027-05-31",{"name":44,"class":45},"University of Pennsylvania","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100635571","phase-4-combatting-muscle-loss-in-obese-adult-patients-on-glp-1-medications-through-dietary-counseling-and-exercise-during-treatment-evaluates-whether-a-12-week-exercise-and-individualized-nutrition-program-can-reduce-muscle-and-bone-loss-and-improve-strength-fitness-and-function-in-obese-adults-on-glp-1-100635571","NCT07554417","Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment Evaluates Whether a 12-week Exercise and Individualized Nutrition Program Can Reduce Muscle and Bone Loss and Improve Strength, Fitness, and Function in Obese Adults on GLP-1","Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment","Inclusion Criteria:\n\n* Age between 40 and 55 years\n* Body Mass Index (BMI) greater than 30\n* Body fat percentage greater than 30% for males and 40% for females\n* Android to gynoid fat ratio greater than 1.0\n* Currently eligible for GLP-1 therapy\n* No diagnosis of Type II diabetes\n\nExclusion Criteria:\n\n* Presence of abnormal ECG findings, including arrhythmias or ischemic changes\n* Hypertensive response to exercise, defined as systolic blood pressure exceeding 250 mmHg or diastolic pressure exceeding 115 mmHg\n* Hypotensive response to exercise, defined as a drop in systolic pressure greater than 10 mmHg with increasing workload\n* VO₂ max below 15 ml\u002Fkg\u002Fmin\n* Borg Rating of Perceived Exertion (RPE) greater than 19 during submaximal workloads\n* Any contraindications to exercise as defined by ACSM guidelines\n* Musculoskeletal limitations that prevent safe participation in exercise","40 Years","55 Years",{"count":57,"type":19},20,[59],"PHASE4","Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing substantial weight loss and favorable metabolic improvements. These medications are now widely prescribed, with estimates suggesting that nearly 12% of Americans are currently using or have previously used GLP-1 therapies. Despite their demonstrated benefits, growing evidence indicates that GLP-1-associated weight loss may be accompanied by unintended reductions in skeletal muscle and bone mass. This potential side effect is of increasing concern, as muscle and bone are essential for metabolic health, physical function, injury prevention, and recovery from illness or surgical intervention.\n\nLoss of skeletal muscle during weight reduction may negatively impact strength, mobility, insulin sensitivity, and long-term health outcomes. These risks may be further compounded in individuals experiencing reduced physical activity, mechanical unloading, or prolonged caloric deficits. In clinical and surgical populations, such as individuals undergoing orthopedic procedures, mechanical unloading and disuse already predispose patients to muscle and bone atrophy. When combined with pharmacologically induced weight loss, these factors may further hinder recovery, impair functional capacity, and compromise musculoskeletal integrity. As GLP-1 therapies are increasingly adopted across diverse populations, understanding how to preserve lean mass and bone health during treatment has become an important clinical and public health priority.\n\nExercise training, particularly resistance training, combined with appropriate nutritional support, has consistently been shown to preserve and enhance skeletal muscle and bone mass during weight loss. Structured exercise interventions can mitigate sarcopenia and osteopenia while improving muscular strength, cardiorespiratory fitness, metabolic health, and overall physical function. Similarly, individualized dietary counseling, particularly when focused on adequate protein intake and nutrient timing, plays a critical role in supporting muscle protein synthesis and skeletal health during caloric restriction. Together, these lifestyle strategies may not only counteract the potential adverse musculoskeletal effects associated with GLP-1 therapy but also enhance treatment efficacy by improving cardiovascular risk profiles, insulin sensitivity, systemic inflammation, and physical resilience.\n\nDespite the growing use of GLP-1 medications, there remains a limited body of prospective research examining structured lifestyle interventions specifically designed to preserve muscle and bone mass during GLP-1-induced weight loss. Addressing this gap is essential to ensure that pharmacological obesity treatments support long-term health, functional independence, and quality of life. Integrating exercise and nutrition interventions into GLP-1 treatment protocols may represent a scalable and clinically meaningful strategy to optimize outcomes and reduce unintended consequences of rapid weight loss.\n\nThe purpose of this study is to evaluate whether a structured lifestyle intervention combining exercise and individualized nutritional counseling can mitigate skeletal muscle mass loss in obese adults undergoing treatment with GLP-1 receptor agonists. The primary objective of this study is to determine whether participation in a structured 12-week exercise program, in conjunction with individualized dietary counseling, preserves skeletal muscle mass and bone mineral density during GLP-1 therapy. Secondary objectives include assessing changes in muscular strength, cardiorespiratory fitness, and overall functional capacity. Findings from this study aim to inform best practices for integrating lifestyle interventions with pharmacological obesity treatments and to support safer, more effective, and functionally protective approaches to weight management in adults receiving GLP-1 therapy.",[62,63,29,64,65],"GLP - 1","Obesity & Overweight","Exercise Intervention","Dietary Assessment",[67,68,69,70],"GLP-1","Semaglutide","obesity","exercise intervention","NOT_YET_RECRUITING","2026-04-21",{"date":74,"type":38},"2026-04-28",{"date":76,"type":19},"2026-04-06",{"date":78,"type":19},"2026-08-06",{"name":80,"class":45},"William Marsh Rice University",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":20,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100600780","phase-2-a-study-of-the-effect-of-s-pindolol-benzoate-acm-0011-on-lean-body-mass-lbm-in-obese-patents-during-proact-1-and-post-semaglutide-therapy-proact-2-100600780","NCT07101939","A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)","A Two-part, Phase 2a Randomized, Part Parallel-group, Double-blind Placebo-controlled Cross-over Multi-center Study to Evaluate the Effect of Two Dose Levels of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass in Obese Patients During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)","PROACT","Key Inclusion Criteria:\n\nEligible for treatment with semaglutide.\n\nHave a BMI of ≥30.0 kg\u002Fm².\n\nKey Exclusion Criteria:\n\nType 2 diabetes mellitus who in the preceding 90 days have either:\n\n* received a GLP-1RA (including semaglutide),\n* had a hypoglycaemic event,\n* lost \\>5 kg weight,\n* had a HBA1C over 10.0%.\n\nAny cardiovascular event within previous 6 months, uncontrolled hypertension, known congestive heart failure, or angina during the past year\n\nKnown severe chronic obstructive pulmonary disease (COPD)\n\nConcomitant use of beta blockers and patients with contra indications to beta blockers","75 Years",{"count":92,"type":19},120,[94],"PHASE2","Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients. Drug treatments like semaglutide that result in weight-loss can also decrease muscle mass. The purpose of this study is to investigate the effect of ACM-001.1 (the study drug) on how much muscle is lost when a person takes it with semaglutide (PROACT 1) and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide (PROACT 2).",[97,29],"Obesity",[99,100,69,101,102,103],"semaglutide","s-pindolol","glp-1","glucagon-like peptide-1 receptor agonist","lean body mass","2026-02-13",{"date":106,"type":38},"2026-02-17",{"date":108,"type":38},"2025-06-23",{"date":110,"type":19},"2027-03",{"name":112,"class":113},"Actimed Therapeutics Ltd","INDUSTRY",7,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":122,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":81},"100572088","ultrasound-detection-of-body-composition-in-critical-care-100572088","NCT06728722","Ultrasound Detection of Body Composition in Critical Care","Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.","Inclusion Criteria:\n\n* females with age 16 with no upper limit\n* American Society of Anesthesiologists (ASA) class I, II or III,\n* admitted to the obstetrics and Gynecology critical care unit\n\nExclusion Criteria:\n\n* Patient refusal","FEMALE","16 Years",{"count":125,"type":19},121,"OBSERVATIONAL","Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.",[29,129,130,131,132],"Extracellular Fluid Alteration","Critical Illness","Pregnancy Complications","Gynecologic Disease",[134,135,136,137],"ultrasound","body composition","critical illness","peripartum and gynecological cases","2026-02-08",{"date":140,"type":38},"2026-02-11",{"date":142,"type":38},"2024-12-15",{"date":144,"type":19},"2026-05-28",{"name":146,"class":45},"Ain Shams University",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":20,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":81},"100616279","preventing-muscle-loss-after-bariatric-surgery-protein-collagen-supplementation-and-resistance-exercise-100616279","NCT07303543","Preventing Muscle Loss After Bariatric Surgery: Protein-Collagen Supplementation and Resistance Exercise","Preventing Muscle Loss in the Early Postoperative Period of Bariatric Surgery With a Combination of Whey Protein, Hydrolyzed Collagen, and Resistance Exercise: A Prospective, Randomized, Controlled Clinical Study","Inclusion Criteria:\n\n* Being between 20-50 years old\n* Body mass index; 35 ≤ BMI\\\u003C 60 kg\u002Fm2\n* Not being pregnant\n* Not being addicted to alcohol and drugs\n* Not having entered menopause\n* No exercise restrictions\n\nExclusion Criteria:\n\n* Having at least one of the following inflammatory bowel diseases, upper gastrointestinal bleeding, advanced psychiatric diseases, cancer, and kidney failure.\n* using statins\n* be pregnant\n* Being addicted to alcohol and drugs\n* to have entered menopause\n* Having exercise restrictions\n* Becoming a professional athlete\n* Having done more than 60 minutes of regular and structured exercise per week in the last year","20 Years","50 Years",{"count":157,"type":19},35,[22],"The aim of this clinical trial is to investigate the effectiveness of collagen, considered a new approach to prevent muscle mass loss after bariatric surgery, and to demonstrate the relationship between this effect and exercise. The key questions it aims to answer are:\n\nDoes whey protein supplementation with collagen combined with resistance exercise prevent muscle mass loss after bariatric surgery? Do whey protein supplementation with collagen combined with resistance exercise affect fat mass after bariatric surgery?\n\nResearchers will compare collagen with whey protein.\n\nThe study groups and interventions to be implemented are summarized below:\n\nGroup 1: Control Group (CG; n: 10) Whey protein supplementation will be administered Vitamin and mineral supplementation will be administered No resistance exercise will be performed The participants will eat according to bariatric surgery nutrition guidelines and perform physical activities.\n\nGroup 2: Whey Protein + Collagen + Exercise Group (WPCEG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.\n\nThey will begin a resistance exercise program 4 weeks after surgery.\n\nGroup 3: Whey Protein + Collagen + No Exercise Group (WPCG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. No resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.\n\nGroup 4: Whey Protein + Exercise Group (WPEG; n: 10) Whey protein supplements will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.\n\nA resistance exercise program will begin at 4 weeks post-operatively.",[161,29],"Bariatric Surgery",[161,163,164,165,166],"Collagen","Resistance exercise","Whey protein","Muscle loss","2025-12-10",{"date":169,"type":38},"2025-12-26",{"date":171,"type":38},"2022-08-02",{"date":173,"type":19},"2026-01-30",{"name":175,"class":45},"Medipol University",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":81},"100614472","mortality-and-muscle-mass-loss-in-critically-ill-patients-100614472","NCT07280039","Mortality and Muscle Mass Loss in Critically Ill Patients.","Mortality and Muscle Mass Loss in Critically Ill Patients: A Prospective, Observational, Multicenter Study.","MUSIC 2","Inclusion Criteria:\n\n* age ≥18 years\n* mechanical ventilation expected for at least 48 hours\n\nExclusion Criteria:\n\n* Clinical Frailty Score above 7 prior admission\n* Neuromuscular disease in previous medical history\n* Amputated lower extremities\n* Trauma of lower extremities involving tights\n* Conditions affecting the nervous system with involvement of the thigh muscle\n* Inability to cooperate during ultrasound examination\n* Inability to perform ultrasound examination on day 7\n\n  9\\. Inability to perform ultrasound examination on day 7",{"count":185,"type":19},386,"The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasoud for measurement the rectus femoris cross sectional area.",[188,29],"Mortality",[188,166,190,191,192],"Muscle ultrasound","Critically ill","Rectus femoris cross area","2025-12-01",{"date":195,"type":38},"2025-12-12",{"date":197,"type":19},"2025-12-15",{"date":199,"type":19},"2026-12-15",{"name":201,"class":45},"Brno University Hospital",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":219,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":81},"100595306","plant-vs-animal-based-protein-sources-as-an-anabolic-and-metabolic-protective-options-for-so-in-older-adults-100595306","NCT07030738","Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults","Plant (Legumes) vs Animal-based (Meat) Protein Sources as an Anabolic and Metabolic-protective Options for Sarcopenic Obesity in Older Adults- A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 55 years or older.\n* Diagnosed with obesity.\n* At risk for sarcopenia, based on at least one of the following: Low score on the validated SARC-F-calf questionnaire (as suggested in prior studies). More than one comorbidity associated with sarcopenic obesity (e.g., diabetes, osteoporosis, cardiovascular disease, etc.). Polypharmacy: taking 8 or more prescribed medications. Evidence of strength or functional impairment, assessed using validated measurements at the baseline visit.\n\nExclusion Criteria:\n\n* Recent use of steroid agents within the past 6 months (replacement therapy is allowed).\n* Uncorrected hypothyroidism: TSH \\> 6 mIU\u002FL.\n* Diagnosis of malignancy within the past 5 years, except for non-melanoma skin cancer.\n* Chronic kidney disease (CKD) at stage \\>1 (due to protein restriction needs).\n* Recent (≤6 months) or unstable cardiovascular condition, or NYHA Class III or higher congestive heart failure.\n* Currently performing resistance training.\n* Currently undergoing nutritional therapy, have recently changed diet (\\\u003C1 month), or are enrolled in active weight-loss programs or therapies (including lifestyle and\u002For pharmacotherapy). Note: Patients stable on GLP-1 agonists or other pharmacotherapy are eligible.\n* Vegetarians\u002Fvegans, or individuals with aversion or allergy to all legumes or all red meat products.\n* Habitual consumption of more than 3 servings\u002Fweek of either legumes or red meat.\n* Other medical, psychiatric conditions, or lab abnormalities that may pose a risk to participation.",{"count":210,"type":19},180,[22],"This study is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Participants will follow a personalized weight loss diet with one high-protein meal each day that includes either red meat, legumes, or both, along with a home-based strength training program. The study will last three months and will include health assessments such as blood tests, muscle and fat measurements, and physical function tests. The goal is to find out which type of protein source is most helpful for improving strength, reducing body fat, and supporting healthy aging.",[214,215,216,217,29,218],"Sarcopenic Obesity","Obesity and Obesity-related Medical Conditions","Obesity (Body Mass Index &gt;30 kg\u002Fm2)","Sarcopenia","Aging",[220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237],"Plant-based diet","Red meat","Legumes","Protein intake","Anabolic diet","Resistance training","Muscle mass","Body composition","Older adults","Functional status","Sarcopenic obesity","Hypocaloric diet","Leucine","Physical function","Metabolic health","Aging population","Nutrition intervention","Randomized controlled trial","2025-06-12",{"date":240,"type":38},"2025-06-22",{"date":242,"type":19},"2025-09",{"date":244,"type":19},"2026-06",{"name":246,"class":247},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":256,"sex":15,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":81},"100564574","d3-creatine-and-skeletal-muscle-in-older-adults-100564574","NCT06630949","D3-Creatine and Skeletal Muscle in Older Adults","Using a Novel Method to Diagnose the Prevalence and Health Impact of Muscle Loss in Older Adults","D3-Cr","Inclusion Criteria:\n\nParticipants will be considered eligible for this study if they are\n\n* Between 60 and 80y (inclusive),\n* Reside in the local (i.e., within 60km of Hamilton) community; and\n* Are willing and able to provide written informed consent.\n\nParticipants must fall into one of three self-reported mobility limitations based on validated screening criteria via a structured phone interview. Potential participants will be asked whether they have any difficulty:\n\n* Walking 800m;\n* Climbing ten steps; and\n* Transferring from\u002Finto a car or bus.\n\nResponse options include:\n\n* Managing without difficulty;\n* Managing without difficulty but with task modification; or\n* Managing with minor difficulty.\n\nExclusion Criteria:\n\n* Participants who self-report more than minor difficulty will be considered to have a mobility disability and excluded.\n* Participants who cannot speak or read English will also be excluded.",true,"60 Years",{"count":259,"type":19},350,"The age-related decline in muscle mass and strength are collectively referred to as sarcopenia. However, the tools currently employed to assess skeletal muscle mass (SMM) (e.g., Dual-energy Xray Absorptiometry; DXA) have substantial drawbacks, and it is known that DXA-lean soft tissue (LST) is generally not associated with health outcomes of interest. Thus, the investigators propose using a novel, non-invasive, stable isotope-labelled probe (Deuterium (D)-labelled creatine (D3-creatine; D3-Cr)) to measure skeletal muscle mass in a large cohort of older individuals. The development and employment of new methods to accurately quantify the biological substrate of sarcopenia, skeletal muscle, are critical for the measure to remain clinically relevant. The plan is to measure 350 persons from the recently established (M3) prospective cohort. There will be measurement of lean soft tissue LST and appendicular LST (aLST) using DXA and compared to D3-Cr-measured SMM (D3-Cr-SMM) at baseline, 12mo, and 24mo (2yr) of follow-up. Physical mobility will also be measured (using various instruments).",[218,29],[263,264,265,266,267,268,269],"aging","muscle","stable isotope tracer","mobility","sarcopenia","creatine","creatinine","2024-10-06",{"date":272,"type":38},"2024-10-08",{"date":274,"type":38},"2023-10-01",{"date":276,"type":19},"2027-06-30",{"name":278,"class":45},"McMaster University",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":15,"minAge":154,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":20,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100562572","branched-chained-amino-acid-supplement-in-patients-undergoing-lower-limb-bone-cancer-curettage-for-bone-metastasis-100562572","NCT06604910","Branched Chained Amino Acid Supplement in Patients Undergoing Lower Limb Bone Cancer Curettage for Bone Metastasis","The Impact of Oral Branched-Chain Amino Acids Under Enhanced Recovery After Surgery on Reducing Postoperative Muscle Loss, Swallowing Difficulties, and Complications After Lower Limb Bone Cancer Curettage for Bone Metastasis","Inclusion Criteria:\n\n* I) The patient has a femoral metastasis and is expected to undergo bone tumor curettage and joint replacement surgery, or the patient has a femoral metastasis and is expected to undergo bone tumor curettage and internal fixation surgery; II) Age between 20 and 80 years; III) Able to take care of themselves independently (Karnofsky Performance Status ≥ 70%, which measures a patient's ability to perform daily activities, with a total score of 100 points. A higher score indicates better self-care ability, and a score of 70 or above indicates the ability to live independently but not to work or perform normal daily activities); IV) Patients have all signed a written informed consent.\n\nExclusion Criteria:\n\n* I) Patients expected to undergo bone tumor curettage and mega prosthesis replacement; II) Patients requiring surgery on both upper and lower limbs; III) Patients requiring surgery on both lower limbs; IV) Patients with simultaneous spinal metastasis; V) Patients likely to undergo a second surgery within 30 days; VI) Patients with metastasis in other locations or a history of metastasis with prior surgeries; VII) Patients with neuromuscular diseases, such as stroke or Parkinson\\&#39;s disease; VIII) Exclusion of patients with other diseases and complications, such as those with concurrent gastric cancer or post-gastrectomy patients requiring additional surgeries due to complications or unstable conditions, patients with New York Heart Association Functional Classification ≥ Class 2 heart disease and thrombotic conditions, patients with Hugh-Jones Classification ≥ Grade 4 lung disease, or those currently receiving insulin therapy; IX) Patients allergic to eggs, soy, or thiamine; X) Patients who are already supplementing BCAAs; XI) Patients with psychiatric disorders that may affect their ability to provide informed consent or comply with the study protocol; XII) If postoperative pathology reveals a diagnosis other than the originally identified cancer metastasis, the case will be excluded.","80 Years",{"count":288,"type":19},40,[22],"Postoperative muscle loss is common in patients with bone metastases undergoing lower limb bone cancer curettage, affecting both limb skeletal muscles and potentially swallowing-related muscles. Rectus femoris thickness, measured via ultrasound on postoperative day seven, is used to assess this loss. Branched-chain amino acids (BCAAs) are important for muscle protein synthesis, but little research exists on whether postoperative oral BCAA supplementation can reduce muscle loss, swallowing function deterioration, and short-term complications. This study investigates if BCAA supplementation from postoperative day one to day 30 can reduce muscle loss (primary endpoint: rectus femoris thickness on day seven) and mitigate swallowing function decline, pharyngeal muscle contraction loss, and complications within three months post-surgery.",[29],[293],"nutrition in bone metastases","2024-09-18",{"date":296,"type":38},"2024-09-20",{"date":298,"type":19},"2024-09-25",{"date":300,"type":19},"2030-12-31",{"name":302,"class":45},"National Taiwan University Hospital",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":20,"phases":313,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":81},"100557261","ketonifast-cyclic-enteral-daytime-feeding-with-ketogenic-nighttime-fasting-100557261","NCT06535815","KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting","KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.","KetoNiFast","Inclusion Criteria:\n\n* written informed consent to participate in this study\n* admission to ICU\n* enteral nutrition\n\nExclusion Criteria:\n\n* Severe liver dysfunction \u002F liver failure (Child Pugh \\>7 points \u002F category B)\n* Severe kidney dysfunction (KDIGO stage 3)\n* Total pancreatectomy \u002F insulin dependent diabetes mellitus (IDDM)\n* Pregnancy \u002F lactation\n* Hemoglobin concentration \\\u003C 80g\u002Fl\n* Severe metabolic disorders \u002F severe autoimmune diseases\n* Refractory metabolic or respiratory acidosis\n* Dysfunction of mitochondrial transport of fatty acids\n* Dysfunction of oxidation of fatty acids\n* Dysfunction of gluconeogenesis, production and reduction of ketones\n* Intermittent Porphyria\n* Severe cardiac arrhythmias \u002F cardiomyopathy\n* Contraindication against enteral nutrition\n* Lack of informed consent",{"count":312,"type":19},130,[22],"A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.",[316,29,317],"Nutrition","Inflammatory Response",[319,320,321],"Ketogenic diet","ketogenic fasting","cyclic enteral nutrition","2024-08-04",{"date":324,"type":38},"2024-08-06",{"date":326,"type":38},"2023-09-01",{"date":328,"type":19},"2026-03-01",{"name":330,"class":45},"University Hospital of Cologne",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":339,"targetDuration":341,"studyType":126,"phases":4,"briefSummary":342,"conditions":343,"keywords":350,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":81},"100488978","impact-of-very-high-protein-content-enteral-nutrition-formulas-on-critically-ill-multiple-trauma-patients-100488978","NCT05647135","ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts","ImpACt of Very High Protein Content Enteral nUtrition Formulas on Protein Metabolism and Residual Gastric Volume in Critically Ill MUltipLe trAuma paTiEnts","ACCUMULATE","Inclusion Criteria:\n\n* Adult patients (\\>18 yrs) admitted to the ICU\n* Multiple trauma (Injury severity score \\> 18)\n* Intubation and mechanical ventilation upon admission in ICU or during the first 24 hours of admission, for at least 48 h\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant women\n* Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation\n* Patients with enteral feeding contraindication 48 h after admission\n* Patients with recent gastrointestinal surgical intervention\n* Patients on chronic therapy with corticosteroids",{"count":340,"type":19},70,"8 Weeks","This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content.\n\n* Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content\n* Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content\n* Differences regarding body composition when using enteral nutrition formulas with different protein content",[344,345,346,347,348,29,349],"Metabolism","Trauma","Nutritional Deficiency","Protein Malnutrition","Gastroparesis","Calorie Malnutrition Protein",[351,352,353,354,135,355,356],"enteral nutrition","multiple trauma","energy target","protein target","gastric residual volume","enteral nutrition intolerance","2024-07-17",{"date":359,"type":38},"2024-07-22",{"date":361,"type":38},"2023-03-01",{"date":363,"type":19},"2024-12-01",{"name":365,"class":45},"Romanian Society for Enteral and Parenteral Nutrition",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":81},"100553652","comparison-of-computed-tomography-data-with-routine-measurements-concerning-bone-and-muscle-health-of-aged-individuals-100553652","NCT06488872","Comparison of Computed Tomography Data With Routine Measurements Concerning Bone and Muscle Health of Aged Individuals","Comparison of Artificial Intelligence-based Analysis of Computed Tomography Data With Routinely Performed Measurements Concerning Bone and Muscle Health of Aged Individuals to Validate Surrogate Parameters for the Aging Population.","SARCATAR","Inclusion Criteria:\n\n* CT examination (thorax, abdomen, pelvis, spine with muscle parts to be visualized) by the responsible in-house radiology department one month before or after the inpatient stay at the UAFP (sarcopenia arm).\n* CT thorax and CT abdomen images of patients from the responsible in-house radiology department and an in-house DEXA measurement. Both examinations may be performed no more than 18 months apart (osteoporosis arm).\n* Diagnostic image quality of CT scans.\n\nExclusion Criteria:\n\n* Presence of a documented refusal.\n* Non-diagnostic image quality\n* Absence of the following functional measurements: Hand strength on both hands, timed-up \\& go test, gait speed.",{"count":375,"type":19},300,"This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals impairments. To address these challenges, the study employs innovative imaging techniques based on artificial intelligence (AI) to accurately assess age-related muscle atrophy. A central approach is to analyze existing computed tomography (CT) images of older adults, using retrospective data to evaluate muscle quality. This method aims to efficiently assess muscle quality without additional resources. AI algorithms analyze fine details of muscle tissue, such as muscle adiposity and density. The algorithm can detect fat content within muscles, which negatively impacts muscle health and functionality, and identify irregularities or abnormalities in muscle fibers. This non-invasive approach is crucial for early detection of muscle atrophy and monitoring treatment success. Integrating AI technologies advances beyond conventional imaging techniques, allowing precise analysis of muscle quality. This method not only offers efficient diagnosis and monitoring of sarcopenia but also opens new avenues for personalized therapeutic approaches and improved patient care. Almost every elderly person has at least one existing CT scan, a common and excellent method of medical imaging for significant health issues. These images can be retrospectively analyzed for muscle health. In addition to imaging techniques, the study includes functional tests such as hand strength and walking speed measurements to assess muscle health and condition. These tests establish objective quality characteristics of muscles and assess the effectiveness of prevention and treatment measures. This research aims to provide early diagnosis and effective treatment strategies for sarcopenia and osteoporosis, ultimately improving the quality of life for the elderly. By leveraging AI and existing medical imaging data, the study promotes efficient, sustainable, and precise healthcare solutions for age-related muscle and bone deterioration.",[217,29,378],"Osteoporosis","2024-07-09",{"date":381,"type":38},"2024-07-11",{"date":40,"type":38},{"date":384,"type":19},"2025-09-01",{"name":386,"class":45},"University Department of Geriatric Medicine FELIX PLATTER",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":256,"sex":15,"minAge":394,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":20,"phases":397,"briefSummary":398,"conditions":399,"keywords":405,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":81},"100501881","yoomi-effect-of-gamified-physical-therapy-exercise-software-on-inpatient-mobility-100501881","NCT05815017","YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility","YOOMI","Inclusion Criteria:\n\n* \\>= 65 years of age\n* English-fluency in reading and speaking\n* Capacity to consent\n* Enrolled in HELP program\n* Attending physician confirms there are no medical contraindications to in-bed exercises\n\nExclusion Criteria:\n\n* Unstable Psychiatric Illness\n* Unstable\u002FCritically Ill Patients requiring ICU-level of care\n* Surgical tube present (e.g. JP drains)\n* Surgery during the hospitalization\n* Bed Rest Activity Order","65 Years",{"count":396,"type":19},80,[22],"Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot\u002Fproof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.",[400,401,402,29,403,404,28],"Weakness, Muscle","Delirium in Old Age","Muscle Atrophy or Weakness","Hospital Acquired Condition","Physical Disability",[406,407,408,409,410,411],"Artificial Intelligence (AI)","Physical Therapy","Hospitalization related muscle atrophy","Hospitalization associated decline","Inpatient rehabilitation","AI driven physical therapy","2024-03-06",{"date":414,"type":38},"2024-03-08",{"date":416,"type":38},"2023-11-29",{"date":418,"type":19},"2024-12",{"name":420,"class":45},"Rutgers, The State University of New Jersey",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":427,"targetDuration":429,"studyType":126,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":4},"100530553","impact-of-skeletal-muscle-quality-and-loss-on-the-outcome-of-liver-transplantation-100530553","NCT06188273","Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation","Inclusion Criteria:\n\n* Adult patients undergoing deceased donor liver transplantation (DDLT) for the first time\n\nExclusion Criteria:\n\n* Pediatric transplants\n* Presence of portal vein tumor thrombus according to imageing before transplantation\n* Presence of macrovascular invasion according to imageing before transplantation\n* Re-transplants\n* Multi-organ transplants\n* Patients who died within 30 days after transplantation\n* Patients diagnosed with skeletal muscle diseases (e.g. muscle atrophy)\n* Patients with serious medical conditions such as heart failure, persistent infection, and renal insufficiency.",{"count":428,"type":19},800,"3 Years","CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.",[432,29,433],"Liver Transplantation","Muscle Quality","2023-12-17",{"date":436,"type":38},"2024-01-03",{"date":438,"type":19},"2024-01-01",{"date":440,"type":19},"2029-01-01",{"name":442,"class":45},"Zhejiang University"]