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Can diet help manage a rare muscle disease? new study seeks answers

NCT ID NCT07535996

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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to understand if diet influences muscle health and daily function in adults with inclusion body myositis (IBM), a rare muscle disease. Researchers will compare 47 adults with IBM to healthy volunteers aged 40 and older. Participants will track their diet and activity at home for four weeks, then undergo body composition and muscle strength tests at a university. The goal is to identify dietary factors that might help manage IBM.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 47 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. Exclusion Criteria (Control Participants): * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Manchester Metropolitan University Institute of Sport

    Manchester, M17EL, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.