IBM Dietary Surveillance Study
Surveying the Dietary Intake, Physical Activity Patterns, Muscle Strength and Morphology of Adults With Inclusion Body Myositis
2 other identifiers
observational
47
1 country
1
Brief Summary
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. The study aims to answer the question: Does diet affect the muscle health and functional ability of people living with IBM? Researchers 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. Participants will: Attend an initial screening visit at the Manchester Metropolitan University Institute of Sport to confirm eligibility and explain study procedures. Complete four weeks of home-based monitoring, including dietary records, physical activity monitoring, and questionnaires about lifestyle and symptoms. Attend a second university visit for assessments of body composition, metabolism, and muscle function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2026
CompletedFirst Posted
Study publicly available on registry
April 17, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 17, 2026
March 1, 2026
8 months
March 12, 2026
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Habitual Daily Protein Intake
Habitual daily protein intake (g/day) estimated using two 3-day weighed food diaries.
Baseline
Habitual Daily Protein Intake Relative to Body Mass
Mean daily protein intake estimated using two 3-day weighed food diaries, normalised to body mass (g/kg/day).
Baseline
Appendicular Lean Mass
Appendicular lean mass (kg) measured using dual-energy X-ray absorptiometry (DXA). Appendicular lean mass represents the sum of lean soft tissue mass from both arms and both legs.
Baseline
Handgrip Strength
Maximal isometric handgrip strength (kg) measured using a hand-held dynamometer. Participants perform three maximal voluntary contractions with each hand; the highest value recorded is used for analysis.
Baseline
Peak Knee Extensor Torque
Peak knee extensor torque (Nm) represents the highest rotational force generated during knee extension across five maximal repetitions using an isokinetic dynamometer.
Baseline
Peak Knee Flexor Torque
Peak knee flexor torque (Nm) represents the highest rotational force generated during knee flexion across five maximal repetitions using an isokinetic dynamometer.
Baseline
sporadic Inclusion Body Myositis Functional Assessment (sIFA)
Functional status as determined by the sIFA total score. The sIFA is an 11-item patient-reported outcome measure evaluating functional ability in individuals with inclusion body myositis, including swallowing, mobility, and hand function. Each item is scored on a 0-10 scale, and item scores are summed to produce a total score ranging from 0 to 110. Lower scores indicate greater functional impairment, while higher scores indicate better functional ability.
Baseline
Activities of Daily Living: Nottingham Extended Activities of Daily Living Scale (NEADL) Total Score
Functional independence measured using NEADL scale. The NEADL is a 22-item patient-reported questionnaire covering mobility, kitchen activities, domestic activities, and leisure activities. Each item is scored from 0 to 3, representing increasing levels of independence. Item scores are summed to produce a total score ranging from 0 to 66, with higher scores indicating greater independence in activities of daily living and lower scores indicating greater functional limitation.
Baseline
Muscle Functional Cross-Sectional Area
Functional cross-sectional area (cm²) of skeletal muscle derived from magnetic resonance imaging (MRI). Functional cross-sectional area represents the estimated contractile muscle area and is calculated from total muscle cross-sectional area adjusted for intramuscular fat fraction.
Baseline
Skeletal Muscle Volume
Muscle volume (cm³) derived from magnetic resonance imaging (MRI) of the thigh and forearm muscles using image segmentation techniques.
Baseline
Secondary Outcomes (24)
Broader Nutrient Intake
Baseline
Serum 25-Hydroxyvitamin D Concentration
Baseline
Resting Energy Expenditure
Baseline
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) Total Score
Baseline
Total Energy Intake
Baseline
- +19 more secondary outcomes
Study Arms (2)
IBM
Individuals living with Inclusion Body Myositis
Healthy Controls
Adults without diagnosed neuromuscular or relevant chronic disease, matched to participants with IBM by age, sex, and habitual physical activity level
Interventions
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.
A finger-prick blood sample to assess serum 25-hydroxyvitamin D concentrations.
Resting energy expenditure measurement via indirect calorimetry.
Magnetic resonance imaging to assess muscle morphology and swallowing-related structures.
A hand-held dynamometer will be used to assess grip strength. An isokinetic dynamometer will be used to assess knee flexor and extensor strength.
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.
Eligibility Criteria
Adults aged 40 years and older will be recruited into two groups: individuals with a confirmed diagnosis of IBM and healthy volunteers without diagnosed neuromuscular or relevant chronic disease. Participants with IBM will be identified through specialist neuromuscular services in the UK, and control participants will be recruited from the local community. Control participants will be frequency-matched to the IBM group by age, sex, and habitual physical activity level.
You may qualify if:
- Age: Adults aged ≥40 years at the time of consent.
- Ability to Provide Informed Consent: Participants must be cognitively capable of providing written, informed consent.
- 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).
- Willingness to Participate: Willing to attend study visits and comply with all study procedures.
- 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.
- Age: Adults aged ≥40 years at the time of consent.
- Ability to Provide Written Informed Consent
- Willingness to Participate
- Matched to IBM participants according to their age and physical activity levels
You may not qualify if:
- Coexisting Neuromuscular or Metabolic Disorders: Presence of other neuromuscular or metabolic disorders that may confound the outcomes of interest.
- Severe Dysphagia: Participants requiring exclusive enteral or parenteral feeding, which would prevent participation in dietary intake assessments.
- 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.
- Contraindications to any Study Procedures: Any condition preventing safe completion of key assessments. For instance: severe osteoporosis contraindicating DXA scanning (T-score \< -3.0), respiratory conditions, severe claustrophobia, severe cognitive impairments or communication barriers that may impair participant ability to comply with study procedures.
- Logistical Concerns: Any other logistical concern, as judged by the CI, that would compromise participant safety or the integrity of study data.
- 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.
- Diagnosed neuromuscular or metabolic Disorder
- Enrolment in an interventional trial within the past 3 months
- Contraindications to any study procedures such as those listed for IBM participants (e.g., DXA, MRI).
- Logistical or safety concerns, as judged by the research team.
- To minimise dietary overlap, individuals living in the same household as an IBM participant will not be eligible.
- Do not meet the physical activity criteria to be appropriately matched to an IBM participant
- Unable to understand written or verbal English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manchester Metropolitan Universitylead
- Northern Care Alliance NHS Foundation Trustcollaborator
- NeuroMuscular Centre (Winsford)collaborator
- Myositis UKcollaborator
Study Sites (1)
Manchester Metropolitan University Institute of Sport
Manchester, M17EL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul T Morgan, PhD
Manchester Metropolitan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2026
First Posted
April 17, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- De-identified individual participant data and supporting materials will be made available following publication of the primary study results and will remain available indefinitely.
- Access Criteria
- Access to de-identified individual participant data and supporting materials will be available to any member of the public, including researchers, clinicians, and other stakeholders. Materials will be hosted in an open-access repository (Open Science Framework) and can be downloaded directly from the project page. Data will be available in standard file formats (e.g., CSV, PDF, or R/Python code files) with a README describing variable definitions, units, and coding to ensure usability and reproducibility.
De-identified individual participant data from all study assessments will be shared.