Health Trials

IBM Dietary Surveillance Study

ConditionInclusion Body Myositis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorManchester Metropolitan University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Whole-Body Dual-Energy X-ray Absorptiometry
  • Anthropometry
  • Capillary Blood Sampling
  • Indirect Calorimetry
  • Magnetic Resonance Imaging
  • Dynamometry
  • Behavioural Monitoring

Treatment groups

47 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Manchester Metropolitan University

Lead sponsor

Northern Care Alliance NHS Foundation Trust

Collaborator

NeuroMuscular Centre (Winsford)

Collaborator

Myositis UK

Collaborator

Source ClinicalTrials.gov