IBM Dietary Surveillance Study

NCT07535996 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • Inclusion Body Myositis

Interventions

RADIATION

Whole-Body Dual-Energy X-ray Absorptiometry

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.

OTHER

Anthropometry

Heights and weight measurements.

OTHER

Capillary Blood Sampling

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

OTHER

Indirect Calorimetry

Resting energy expenditure measurement via indirect calorimetry.

OTHER

Magnetic Resonance Imaging

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

OTHER

Dynamometry

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

OTHER

Behavioural Monitoring

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.

Sponsors & Collaborators

  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER
  • NeuroMuscular Centre (Winsford)

    collaborator UNKNOWN
  • Myositis UK

    collaborator UNKNOWN
  • Manchester Metropolitan University

    lead OTHER

Principal Investigators

  • Paul T Morgan, PhD · Manchester Metropolitan University

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535996 on ClinicalTrials.gov