An observational study in Inclusion Body Myositis, sponsored by Manchester Metropolitan University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Manchester Metropolitan University · Observational
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). Additionally, participants will complete a Food Frequency Questionnaire, which asks how often different food items have been consumed over the past year. Throughout this period, participants will also complete the series of validated questionnaires at their own pace. These include a Quality of Life Questionnaire (Short Form-36v2) for overall health and wellbeing, the Nottingham Extended Activities of Daily Living (NEADL) Scale for independence in daily activities, the Modified Fatigue Impact Scale (MFIS), the Visual Analogue Scale (VAS) for pain, the Pittsburgh Sleep Quality Index (PSQI), and the SWAL-QOL questionnaire, which assesses how swallowing impacts quality of life.
After the home-based data collection is complete, participants will return to the IoS for a single laboratory based testing session lasting approximately 3-4 hours. In preparation for this visit, participants will be asked to fast for at least three hours, avoid caffeine for 12 hours, and alcohol for 24 hours. They will also be advised to wear comfortable sports clothing with no or minimal metal components. At the start of the visit, height and weight will be recorded to calculate body mass index. Limb dominance will be ascertained. A small finger-prick blood sample will be taken to measure serum 25(OH)D. Resting metabolism will then be measured using indirect calorimetry. Following this, a whole-body DXA scan will be used to assess body composition, including total and regional fat mass, lean mass, and bone mineral density. This scan will only be undertaken once the participant completes the X-ray Imaging Checklist. Muscle strength and function will be assessed next. Leg strength will be evaluated using an isokinetic dynamometer. Handgrip strength will also be measured using a handheld dynamometer. Finally, participants will undergo an MRI scan lasting approximately 45 minutes. Images will be taken of the thigh and forearm muscles, as well as the head and neck, to assess muscle size, fat infiltration, inflammation, and swallowing function. Standard MRI safety procedures will be followed, including a repeat of the MRI safety checklist prior to scanning.
With respect to the study's primary outcome (relationships between habitual dietary protein intake and total lean mass, as well as muscle strength and physical function measures) correlation analyses will be used to explore the relationships between continuous variables. Depending on data distribution, Pearson's correlation coefficients (parametric) or Spearman's rho (non-parametric) will be used to examine associations between protein intake (g/day, g/kg/day) and a) total lean mass/ fat-free mass (DXA), b) muscle strength (grip strength, knee extensor and flexor torque) and c) Functional capacity (sIFA and NEADL scores).
Multiple linear regression models will be used to assess the predictive value of dietary variables (e.g., protein intake, total energy intake) on muscle-related outcomes (e.g., lean mass, strength, MRI-derived muscle volume). Models will adjust for relevant covariates, including age, sex, body mass index, and physical activity. These models will help establish whether dietary intake independently predicts muscle health beyond demographic and lifestyle factors.
Between-group comparisons for continuous secondary outcomes will use independent samples t-tests or Mann Whitney U tests, as appropriate. ANCOVA will be applied for adjusted group comparisons. For MRI-derived outcomes, two-way mixed ANOVA will examine group × region effects, with post-hoc Bonferroni correction. Friedman tests will be used for repeated non-parametric comparisons where needed. Associations between dietary, metabolic, and functional outcomes will also be explored using correlation and regression techniques, as have been described.
Subgroup analyses will be performed within the IBM group to assess how disease duration, physical activity level, or swallowing severity influence dietary intake, body composition, and function. Stratification may include disease duration (\<5 vs. ≥5 years), biological sex (male vs. female) and dysphagia severity (Swal-QOL scores) differences between subgroups will be tested using ANOVA or Kruskal-Wallis tests. Interaction effects may be examined via factorial ANOVA.
This research is sponsored by ManMet University and funded by both the ManMet Faculty of Science and Engineering and Myositis UK.
49 studies on the registry are indexed under Myositis, Inclusion Body; 11 are open to participants now.
This study's planned enrollment of 47 is below the median of 80 across 17 observational studies indexed under Myositis, Inclusion Body.
Browse Myositis, Inclusion Body studies →Manchester Metropolitan University is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria (Adults with IBM):
Inclusion Criteria (Control Participants):
Exclusion Criteria (Adults with IBM):
Exclusion Criteria (Control Participants):
Individuals living with Inclusion Body Myositis
Radiation: Whole-Body Dual-Energy X-ray Absorptiometry · Other: Anthropometry · Other: Capillary Blood Sampling · Other: Indirect Calorimetry · Other: Magnetic Resonance Imaging · Other: Dynamometry · Other: Behavioural Monitoring
Adults without diagnosed neuromuscular or relevant chronic disease, matched to participants with IBM by age, sex, and habitual physical activity level
Radiation: Whole-Body Dual-Energy X-ray Absorptiometry · Other: Anthropometry · Other: Capillary Blood Sampling · Other: Indirect Calorimetry · Other: Magnetic Resonance Imaging · Other: Dynamometry · Other: Behavioural Monitoring
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.
Heights and weight measurements.
A finger-prick blood sample to assess serum 25-hydroxyvitamin D concentrations.
Resting energy expenditure measurement via indirect calorimetry.
Magnetic resonance imaging to assess muscle morphology and swallowing-related structures.
A hand-held dynamometer will be used to assess grip strength. An isokinetic dynamometer will be used to assess knee flexor and extensor strength.
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.
Habitual Daily Protein Intake
Habitual daily protein intake (g/day) estimated using two 3-day weighed food diaries.
Time frame: Baseline
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
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
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
Peak Knee Extensor Torque
Peak knee extensor torque (Nm) represents the highest rotational force generated during knee extension across five maximal repetitions using an isokinetic dynamometer.
Time frame: Baseline
Peak Knee Flexor Torque
Peak knee flexor torque (Nm) represents the highest rotational force generated during knee flexion across five maximal repetitions using an isokinetic dynamometer.
Time frame: Baseline
sporadic Inclusion Body Myositis Functional Assessment (sIFA)
Functional status as determined by the sIFA total score. The sIFA is an 11-item patient-reported outcome measure evaluating functional ability in individuals with inclusion body myositis, including swallowing, mobility, and hand function. Each item is scored on a 0-10 scale, and item scores are summed to produce a total score ranging from 0 to 110. Lower scores indicate greater functional impairment, while higher scores indicate better functional ability.
Time frame: Baseline
Activities of Daily Living: Nottingham Extended Activities of Daily Living Scale (NEADL) Total Score
Functional independence measured using NEADL scale. The NEADL is a 22-item patient-reported questionnaire covering mobility, kitchen activities, domestic activities, and leisure activities. Each item is scored from 0 to 3, representing increasing levels of independence. Item scores are summed to produce a total score ranging from 0 to 66, with higher scores indicating greater independence in activities of daily living and lower scores indicating greater functional limitation.
Time frame: Baseline
Muscle Functional Cross-Sectional Area
Functional cross-sectional area (cm²) of skeletal muscle derived from magnetic resonance imaging (MRI). Functional cross-sectional area represents the estimated contractile muscle area and is calculated from total muscle cross-sectional area adjusted for intramuscular fat fraction.
Time frame: Baseline
Skeletal Muscle Volume
Muscle volume (cm³) derived from magnetic resonance imaging (MRI) of the thigh and forearm muscles using image segmentation techniques.
Time frame: Baseline
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
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
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
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
Total Energy Intake
Mean daily energy intake (kcal/day) estimated from two 3-day weighed food diaries.
Time frame: Baseline
Muscle T2 Relaxation Time
T2 relaxation time (ms) of thigh and forearm skeletal muscles measured using magnetic resonance imaging (MRI) and derived from multi-echo T2 mapping sequences.
Time frame: Baseline
Maximum Laryngeal Elevation
Maximum superior displacement of the larynx (mm) measured from real-time magnetic resonance imaging (MRI) recordings obtained during saliva swallowing (dry swallow) using sagittal imaging. The measurement represents the distance travelled by the larynx from its resting position to the point of maximum elevation during the swallowing sequence.
Time frame: Baseline
Time to Peak Laryngeal Elevation
Time to peak laryngeal elevation (ms) measured from real-time magnetic resonance imaging (MRI) recordings obtained during saliva swallowing (dry swallow). The measurement represents the time interval from swallow initiation to the point of maximum superior displacement of the larynx.
Time frame: Baseline
Duration of Upper Oesophageal Sphincter Opening
Duration of upper oesophageal sphincter opening (ms) measured from real-time magnetic resonance imaging (MRI) recordings obtained during saliva swallowing (dry swallow) using sagittal imaging. The measurement represents the time interval during which the upper oesophageal sphincter remains open during the swallowing sequence.
Time frame: Baseline
Total Swallow Duration
Total swallow duration (ms) measured from real-time magnetic resonance imaging (MRI) recordings obtained during saliva swallowing (dry swallow). The measurement represents the time interval from swallow initiation to completion of the swallowing sequence.
Time frame: Baseline
Glottal Closure Duration
Duration of glottal closure (ms) measured from real-time magnetic resonance imaging (MRI) recordings obtained during saliva swallowing (dry swallow). The measurement represents the time interval during which the vocal folds remain closed during the swallowing sequence.
Time frame: Baseline
Total Physical Activity Volume
Total physical activity volume (mg) derived from wrist- and thigh-worn accelerometers worn continuously for 7 days. Physical activity volume is calculated from raw acceleration signals and expressed as mean acceleration over the monitoring period.
Time frame: Baseline
Daily Sedentary Time
Sedentary time (minutes/day) derived from accelerometer recordings collected over a 7-day monitoring period. Sedentary behaviour is identified from posture and movement classification algorithms applied to wrist- and thigh-worn accelerometer data and expressed as the average number of minutes per day spent sedentary.
Time frame: Baseline
Average Daily Step Count
Daily step count (steps/day) derived from wrist- and thigh-worn accelerometer recordings collected over a 7-day monitoring period. Step detection algorithms identify walking-related movements and calculate the average number of steps accumulated per day.
Time frame: Baseline
Total Sleep Time
Total sleep time (hours/night) derived from wrist-worn accelerometer recordings collected over a 7-day monitoring period. Sleep duration represents the total time spent asleep each night based on accelerometer-derived sleep detection algorithms.
Time frame: Baseline
Sleep Efficiency
Sleep efficiency (%) derived from wrist-worn accelerometer recordings collected over a 7-day monitoring period. Sleep efficiency represents the proportion of time spent asleep relative to the total time spent in bed.
Time frame: Baseline
Total Fat Mass
Total body fat mass (kg) measured using dual-energy X-ray absorptiometry (DXA). The measurement represents the total mass of adipose tissue derived from whole-body DXA scanning.
Time frame: Baseline
Bone Mineral Content
Bone mineral content (g) measured using dual-energy X-ray absorptiometry (DXA). Bone mineral content represents the total amount of mineral contained within bone tissue as determined from whole-body DXA scanning.
Time frame: Baseline
Bone Mineral Density
Bone mineral density (g/cm²) measured using dual-energy X-ray absorptiometry (DXA). Bone mineral density represents the mineral content of bone normalized to bone area derived from DXA imaging.
Time frame: Baseline
Short Form-36 Health Survey (SF-36v2) Physical and Mental Health Scores
Health-related quality of life measured using theSF-36v2. The questionnaire contains 36 items across eight domains including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, and mental health. Responses are transformed into domain scores ranging from 0 to 100, where higher scores represent better perceived health status and lower scores represent poorer health-related quality of life.
Time frame: Baseline
Pain Intensity
Self-reported pain intensity measured using a Visual Analogue Scale (VAS). Participants indicate their perceived level of whole-body pain on a 100-mm horizontal line, anchored by "no pain" at 0 mm and "worst imaginable pain" at 100 mm. The recorded value corresponds to the distance in millimetres from the lower anchor point, with higher values indicating greater pain intensity.
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI) Global Score
Subjective sleep quality measured using the PSQI. The PSQI is a 19-item questionnaire generating seven component scores related to sleep duration, disturbances, latency, efficiency, medication use, daytime dysfunction, and perceived sleep quality. Component scores (0-3) are summed to produce a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: Baseline
Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score
Swallowing-related quality of life measured using the SWAL-QOL. The instrument contains 44 items across domains including swallowing burden, eating duration, communication, mental health, and social functioning. Responses are transformed to domain scores ranging from 0 to 100, with higher scores indicating better swallowing-related quality of life and lower scores indicating greater dysphagia-related impairment.
Time frame: Baseline
Body Mass Index
Body mass index (kg/m²) calculated from measured body weight and height. Body weight will be measured using calibrated digital scales and recorded in kilograms (kg). Height will be measured using a stadiometer or estimated from segmental arm span where standing height cannot be measured due to posture limitations (m). Body mass index is calculated as body weight (kg) divided by height squared (m²).
Time frame: Baseline
Plan to share: Yes — De-identified individual participant data from all study assessments will be shared.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Manchester Metropolitan University