Metabolism and Nutrition in MND

MET-MND is a single-centre observational feasibility study conducted within Lane Fox Respiratory Services at Guy's and St Thomas' NHS Foundation Trust. The study will assess the feasibility, acceptability, tolerability and data completeness of collecting metabolic, nutritional and body composition measurements in adults with motor neurone disease during the routine respiratory clinic pathway.

Approximately 12-15 participants will complete one study visit aligned with a routine clinic appointment. The study visit is expected to take approximately 1-1.5 hours. Participants will subsequently complete a 7-day food diary at home.

Metabolic rate will be measured using indirect calorimetry with the Q-NRG+ indirect calorimeter. The assessment will be performed while the participant is resting, using either a ventilated canopy hood or mask according to participant comfort and clinical suitability. The study will assess whether indirect calorimetry can be completed successfully and whether the hood or mask is more suitable for people with MND.

Nutritional assessment will include weight, height, body mass index, percentage weight loss and Subjective Global Assessment. Body composition will be assessed using bioelectrical impedance analysis and skinfold measurements. Participants will also complete the ALS Functional Rating Scale-Revised to record how MND affects day-to-day function.

Participants will be asked to record their food and drink intake for seven consecutive days using the Nutritics Libro app or a paper food diary. The diary will be analysed to estimate energy and protein intake. Assistance with completing the diary may be provided when required.

Participants will be asked a small number of questions about the acceptability of undergoing a Dual-Energy X-ray Absorptiometry scan in future research. No DEXA scan will be performed as part of this feasibility study.

Study feasibility will be evaluated using assessment completion, data completeness, time required, participant acceptability and tolerability, and practical or operational barriers encountered during delivery. Reasons for incomplete assessments, such as fatigue, breathlessness, positioning difficulties or equipment limitations, will be recorded.

Measurements will follow written study procedures. Operator-dependent measurements, including skinfold measurements, will be performed in duplicate or triplicate as specified in the protocol. Analyses will be descriptive and will summarise feasibility measures using frequencies, percentages, means with standard deviations, or medians with interquartile ranges, as appropriate. Reasons for non-completion and barriers to delivery will be summarised narratively.

Findings will be used to refine and optimise the assessment procedures, evaluate participant burden and inform the design of future observational research investigating metabolism and nutrition in MND.

Primary outcomes

• Percentage of planned metabolic, nutritional and body composition assessments completed [From Day 1 through Day 8. Day 1: single study visit. Days 2-8: seven days following the visit for diary completion]: For each participant, completion status will be recorded for the following planned assessments: indirect calorimetry, Subjective Global Assessment, weight and height measurements, bioelectrical impedance analysis, skinfold measurements, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, DEXA acceptability questions and the 7-day food diary. The number and percentage of participants completing each assessment will be reported separately. Reasons for non-completion will also be recorded.
• Percentage of Required Data Fields Completed for Each Planned Study Assessment [From Day 1 through Day 8.]: Data completeness will be assessed separately for indirect calorimetry, Subjective Global Assessment, anthropometry, bioelectrical impedance analysis, skinfold measurements, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, DEXA acceptability questions and the 7-day food diary. The percentage of completed data fields will be reported for each assessment. Reasons for missing data will be recorded.

Secondary outcomes

• Participant acceptability and tolerability: number of participants unable to complete each assessment due to acceptability or tolerability of study assessments [From Day 1 through Day 8]: Participant acceptability and tolerability will be assessed for the metabolic, nutritional and body composition procedures. The number and percentage of participants who complete, stop, decline or require adaptation of each assessment will be summarised. Recorded reasons may include discomfort, fatigue, breathlessness, claustrophobia, positioning difficulty or other participant-reported or clinical factors.
• Time taken to complete each in clinic study assessment [Day 1]: The time taken to complete each metabolic, nutritional and body composition assessment will be recorded in minutes: will include indirect calorimetry, Subjective Global Assessment, anthropometry, bioelectrical impedance analysis, skinfold measurements, the ALS Functional Rating Scale-Revised and the DEXA acceptability questions.
• Practicality of integrating assessments into the routine respiratory clinic pathway: percentage completing all in-clinic assessments during one routine clinic visit [Day 1]: The number and percentage of participants for whom all planned in-clinic assessments are completed within the single routine clinic visit will be reported. Operational factors affecting delivery, including room availability, equipment availability, workflow, participant positioning and need for breaks or adaptations, will be recorded and summarised descriptively.
• Completion of Indirect Calorimetry using a canopy hood or mask [Day 1]: The number and percentage of participants who complete indirect calorimetry will be reported by measurement method: ventilated canopy hood or mask. Any need to stop or adapt the procedure and the reasons for non-completion will be recorded.
• Number of Days Completed in the 7-Day Food Diary [Day 2-8]: The number of diary days completed by each participant using the Nutritics Libro app or paper diary will be recorded, with a possible range of 0-7 days. The number and percentage of participants completing all seven days will also be reported. The availability of information required to estimate energy and protein intake, support required and reasons for incomplete diary data will be summarised.
• Participant Responses to the DEXA Acceptability Questions [Day 1]: Responses to the study-specific DEXA acceptability questions will be summarised using the response options specified in the questionnaire. The questions assess whether participants might consider undergoing a DEXA scan in future research and identify practical concerns that could affect acceptability. No DEXA scan will be performed in this study.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult MND patients aged 18 years or over at the time of giving consent.
* Newly referred to the specialist respiratory service for assessment

Exclusion Criteria:

* Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid
* Inability to understand the study's protocol (cognitive disorders)

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• Gillian Radcliffe, Study chair, Guy's and St Thomas' NHS Foundation Trust