IBM Dietary Surveillance Study (NCT07535996) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
IBM Dietary Surveillance Study
United Kingdom47 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Adults with IBM):
* Diagnosis of Inclusion Body Myositis: As defined by the revised European Neuromuscular Centre 2013 diagnostic criteria (Definite or Probable IBM)
* 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.
Inclusion Criteria (Control Participants):
* 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
Exclusion Criteria (Adults with IBM):
* Coexisting Neuromuscular or Metabolic Disorders: Presence of other neuromuscular or metabolic di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Habitual Daily Protein Intake
Timeframe: Baseline
2
Habitual Daily Protein Intake Relative to Body Mass
Timeframe: Baseline
3
Appendicular Lean Mass
Timeframe: Baseline
4
Handgrip Strength
Timeframe: Baseline
5
Peak Knee Extensor Torque
Timeframe: Baseline
6
Peak Knee Flexor Torque
Timeframe: Baseline
7
sporadic Inclusion Body Myositis Functional Assessment (sIFA)
Timeframe: Baseline
8
Activities of Daily Living: Nottingham Extended Activities of Daily Living Scale (NEADL) Total Score