[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634154":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":54,"centralContacts":58,"locations":67,"responsibleParty":83,"collaborators":85,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":10,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":10,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":118,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Manchester Metropolitan University","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"IBM",null,"Individuals living with Inclusion Body Myositis",[13,14,15,16,17,18,19],"Radiation: Whole-Body Dual-Energy X-ray Absorptiometry","Other: Anthropometry","Other: Capillary Blood Sampling","Other: Indirect Calorimetry","Other: Magnetic Resonance Imaging","Other: Dynamometry","Other: Behavioural Monitoring",{"label":21,"type":10,"description":22,"interventionNames":23},"Healthy Controls","Adults without diagnosed neuromuscular or relevant chronic disease, matched to participants with IBM by age, sex, and habitual physical activity level",[13,14,15,16,17,18,19],[25,30,34,38,42,46,50],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"RADIATION","Whole-Body Dual-Energy X-ray Absorptiometry","A total body exposure scan to yield measurements of whole-body and regional body composition, including total fat mass, appendicular fat-free mass, bone mineral content, and bone mineral density.",[21,9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Anthropometry","Heights and weight measurements.",[21,9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Capillary Blood Sampling","A finger-prick blood sample to assess serum 25-hydroxyvitamin D concentrations.",[21,9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Indirect Calorimetry","Resting energy expenditure measurement via indirect calorimetry.",[21,9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Magnetic Resonance Imaging","Magnetic resonance imaging to assess muscle morphology and swallowing-related structures.",[21,9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Dynamometry","A hand-held dynamometer will be used to assess grip strength. An isokinetic dynamometer will be used to assess knee flexor and extensor strength.",[21,9],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":10},"Behavioural Monitoring","Encompassing food records, dual accelerometery and questionnaires, including a food frequency questionnaire, the sIBM Physical Functioning Assessment (s-IFA), the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD), a quality of life questionnaire (Short Form-36v2), the Nottingham Extended ADL Scale, Modified Fatigue Impact Scale (MFIS), a visual analogue scale for pain, the Pittsburgh Sleep Quality Index (PSQI) and SWAL-QOL questionnaires.",[21,9],[55],{"name":56,"affiliation":5,"role":57},"Paul T Morgan, PhD","STUDY_DIRECTOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":10,"email":63},"Charlotte Emily Linscott, BSc","CONTACT","+44 161 247 5100","charlotte.linscott@stu.mmu.ac.uk",{"name":65,"role":61,"phone":62,"phoneExt":10,"email":66},"Dr Paul T Morgan, PhD","p.morgan@mmu.ac.uk",[68],{"facility":69,"status":10,"city":70,"state":10,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Manchester Metropolitan University Institute of Sport","Manchester","M17EL","United Kingdom","UK",{"type":75,"coordinates":76},"Point",[77,78],-2.23743,53.48095,{"lat":78,"lon":77},[81],{"name":82,"role":61,"phone":62,"phoneExt":10,"email":66},"Dr Paul T Morgan",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[86,88,91],{"name":87,"class":6},"Northern Care Alliance NHS Foundation Trust",{"name":89,"class":90},"NeuroMuscular Centre (Winsford)","UNKNOWN",{"name":92,"class":90},"Myositis UK","100634154","ibm-dietary-surveillance-study-100634154",false,"NCT07535996","IBM Dietary Surveillance Study","Surveying the Dietary Intake, Physical Activity Patterns, Muscle Strength and Morphology of Adults With Inclusion Body Myositis","Inclusion Criteria (Adults with IBM):\n\n* Diagnosis of Inclusion Body Myositis: As defined by the revised European Neuromuscular Centre 2013 diagnostic criteria (Definite or Probable IBM)\n* Age: Adults aged ≥40 years at the time of consent.\n* Ability to Provide Informed Consent: Participants must be cognitively capable of providing written, informed consent.\n* Disease Progression: Participants must be able to walk short distances, with or without the use of an assistive aid (e.g., a cane or frame) for balance, so that they can undertake study procedures without safety concerns. Must be able to consume solid or modified-texture food, with or without dysphagia adaptations (i.e., not exclusively tube-fed).\n* Willingness to Participate: Willing to attend study visits and comply with all study procedures.\n\nInclusion Criteria (Control Participants):\n\n* Disease-Free: Control participants must be generally healthy, with no known myopathies or metabolic diseases. They must not have any conditions that, in the judgement of a clinician, would compromise their safety, impair their ability to complete study procedures, or influence study outcomes.\n* Age: Adults aged ≥40 years at the time of consent.\n* Ability to Provide Written Informed Consent\n* Willingness to Participate\n* Matched to IBM participants according to their age and physical activity levels\n\nExclusion Criteria (Adults with IBM):\n\n* Coexisting Neuromuscular or Metabolic Disorders: Presence of other neuromuscular or metabolic disorders that may confound the outcomes of interest.\n* Severe Dysphagia: Participants requiring exclusive enteral or parenteral feeding, which would prevent participation in dietary intake assessments.\n* Enrolment in an interventional trial within the past 3 months: Participation in an interventional study within the past 3 months involving interventions that may affect dietary habits, physical activity, or muscle metabolism.\n* Contraindications to any Study Procedures: Any condition preventing safe completion of key assessments. For instance: severe osteoporosis contraindicating DXA scanning (T-score \\\u003C -3.0), respiratory conditions, severe claustrophobia, severe cognitive impairments or communication barriers that may impair participant ability to comply with study procedures.\n* Logistical Concerns: Any other logistical concern, as judged by the CI, that would compromise participant safety or the integrity of study data.\n* English Comprehension: Participants will be excluded if they are unable to understand written or verbal English to a degree that would impair their ability to provide informed consent or fully understand the study procedures.\n\nExclusion Criteria (Control Participants):\n\n* Diagnosed neuromuscular or metabolic Disorder\n* Enrolment in an interventional trial within the past 3 months\n* Contraindications to any study procedures such as those listed for IBM participants (e.g., DXA, MRI).\n* Logistical or safety concerns, as judged by the research team.\n* To minimise dietary overlap, individuals living in the same household as an IBM participant will not be eligible.\n* Do not meet the physical activity criteria to be appropriately matched to an IBM participant\n* Unable to understand written or verbal English",true,"ALL","40 Years",{"count":104,"type":105},47,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to understand how diet may influence the disease characteristics of inclusion body myositis (IBM). Research findings will help determine whether dietary factors could play a role in managing IBM.\n\nThe study aims to answer the question: Does diet affect the muscle health and functional ability of people living with IBM?\n\nResearchers will compare adults with IBM to healthy volunteers aged 40 years and older. This comparison will help to identify which findings are related to normal ageing and which are specific to IBM.\n\nParticipants will:\n\nAttend an initial screening visit at the Manchester Metropolitan University Institute of Sport to confirm eligibility and explain study procedures.\n\nComplete four weeks of home-based monitoring, including dietary records, physical activity monitoring, and questionnaires about lifestyle and symptoms.\n\nAttend a second university visit for assessments of body composition, metabolism, and muscle function.",[109],"Inclusion Body Myositis",[109,9,111,112,113,114,115,116,117],"Skeletal muscle","Aging","Muscle function","Muscle strength","Case-control study","Diet","Nutrition","NOT_YET_RECRUITING","2026-04-10",{"date":121,"type":122},"2026-04-17","ACTUAL",{"date":124,"type":105},"2026-04-30",{"date":126,"type":105},"2026-12-31",{"name":5,"class":6},1]