Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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 population

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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Whole-Body Dual-Energy X-ray Absorptiometry

    Radiation

    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.

  • Anthropometry

    Other intervention

    Heights and weight measurements.

  • Capillary Blood Sampling

    Other intervention

    A finger-prick blood sample to assess serum 25-hydroxyvitamin D concentrations.

  • Indirect Calorimetry

    Other intervention

    Resting energy expenditure measurement via indirect calorimetry.

  • Magnetic Resonance Imaging

    Other intervention

    Magnetic resonance imaging to assess muscle morphology and swallowing-related structures.

  • Dynamometry

    Other intervention

    A hand-held dynamometer will be used to assess grip strength. An isokinetic dynamometer will be used to assess knee flexor and extensor strength.

  • Behavioural Monitoring

    Other intervention

    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.

Treatment groups

47 Participants
are divided into 2 treatment groups
Group A: IBM7 interventions
Group B: Healthy Controls7 interventions

Trial outcomes

Primary outcomes

1

Habitual Daily Protein Intake

Habitual daily protein intake (g/day) estimated using two 3-day weighed food diaries.

Time frame
Baseline
2

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).

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Secondary outcomes

1

Broader Nutrient Intake

Whilst protein intake (absolute and relative) will be a primary outcome for the study, mean daily intake of other macro and micronutrients (g or mg or µg per day) will also be estimated from two 3-day weighed food diaries.

Time frame
Baseline
2

Serum 25-Hydroxyvitamin D Concentration

Serum 25-hydroxyvitamin D concentration (nmol/L) measured from a capillary blood sample obtained via finger-prick sampling.

Time frame
Baseline
3

Resting Energy Expenditure

Resting energy expenditure (kcal/day) measured using indirect calorimetry. Resting energy expenditure will be calculated from respiratory gas exchange measurements using standard metabolic equations.

Time frame
Baseline
4

Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) Total Score

Self-reported physical activity measured using the PASIPD. The PASIPD is a 13-item questionnaire capturing the frequency and duration of leisure, household, and occupational physical activities performed over the previous 7 days. Responses are weighted according to metabolic equivalent (MET) values and summed to produce a total physical activity score ranging from 0 to approximately 199 MET-hours per day, with higher scores indicating higher levels of physical activity.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Manchester Metropolitan University

Lead sponsor

Northern Care Alliance NHS Foundation Trust

Collaborator

NeuroMuscular Centre (Winsford)

Collaborator

Myositis UK

Collaborator

Source ClinicalTrials.gov

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