IBM Dietary Surveillance Study

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.

This study will employ an observational, case-control design. A sample size of 32 participants with inclusion body myositis (IBM) has been determined based on a power calculation designed to detect a strong association (r = ±0.5) between dietary protein practices and various outcome measures related to muscle mass and function. Using a two-tailed test with an alpha level of 0.05 and power of 80% (β = 0.2), the analysis indicated a required sample size of 29 participants. The sample size equation used was appropriate for Pearson's Correlation analysis. To account for an estimated 10% dropout rate, the final target recruitment number is 32. In addition, 15 age- and activity-matched control participants will be recruited. Power calculations for comparisons between IBM and control groups returned lower sample size requirements, reflecting the lower variability typically observed in healthy populations. Identification of participants with IBM will be carried out at the Tertiary Neuromuscular Service, Salford Royal Hospital (Manchester, UK), and the Neuromuscular Centre (Winsford, Cheshire, UK). Those identified will be approached in clinic or by email with a Participant Information Sheet, the study poster and a Consent to Contact Form. The completed Consent to Contact Form will allow the Manchester Metropolitan (ManMet) research team to follow up with an invitation to a screening visit at the ManMet Institute of Sport (IoS)- a phone call or email. Control participants will be recruited from the local community. If agreed, a phone call will take place to arrange a screening and enrolment visit. The screening visit to the IoS will last up to 1.5 hours but may end prematurely if the participant is found to be ineligible. During the visit, participants will meet with a researcher who will provide a detailed explanation of the study, including time commitment, risks, and participant rights. Informed consent will then be obtained. Participants will then complete four questionnaires to highlight any contraindications to testing and ensure appropriate matching between the disease and control group. These include: a Demographic and General Health Questionnaire, the sIBM Physical Functioning Assessment, an MRI Safety Checklist and the Physical Activity Scale for Individuals with Physical Disabilities. At the end of this visit, participants will be fitted with two activity monitors secured using medical-grade adhesive (one on the wrist and one on the thigh). They will also be given a paper-based food record or shown the Libro App that will serve as a digital alternative, and a set of questionnaires. Participants will then complete a four-week home-based monitoring period. During this time, they will wear the activity monitors continuously for seven days to record physical activity, sedentary behaviour, and sleep patterns. They will also complete two 3-day food diaries, spaced three weeks apart, to capture dietary intake (food and drink, excluding water). Add Покажи пълното описание...

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