Metabolism and Nutrition in MND
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
Motor neurone disease (MND) is a progressive neurological condition that can affect movement, speech, swallowing and breathing. Weight loss and malnutrition are common in people with MND and may be caused by factors including swallowing difficulties, reduced food intake, fatigue, breathlessness, loss of muscle mass and changes in the amount of energy the body uses at rest.
Resting energy expenditure can be measured using indirect calorimetry. However, there is limited evidence about whether comprehensive metabolic, nutritional and body composition assessments can be completed acceptably and practically by people with MND during routine clinical appointments.
MET-MND is a single-centre observational feasibility study involving approximately 12-15 adults with MND referred to a specialist respiratory service. Participants will complete one study visit aligned with a routine clinic appointment, followed by a 7-day food diary at home.
The study will evaluate the acceptability, tolerability, practicality, completion and data completeness of metabolic, nutritional and body composition assessments. Findings will be used to refine study procedures and inform the design of future research investigating metabolism and nutrition in people with MND.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult MND patients aged 18 years or over at the time of giving consent.
Newly referred to the specialist respiratory service for assessment
Disqualifiers
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)
Trial population
Hospital outpatient department
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of planned metabolic, nutritional and body composition assessments completed
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.
Time frame
From Day 1 through Day 8. Day 1: single study visit. Days 2-8: seven days following the visit for diary completion2
Percentage of Required Data Fields Completed for Each Planned Study Assessment
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.
Time frame
From Day 1 through Day 8.Secondary outcomes
1
Participant acceptability and tolerability: number of participants unable to complete each assessment due to acceptability or tolerability of study assessments
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 frame
From Day 1 through Day 82
Time taken to complete each in clinic study assessment
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.
Time frame
Day 13
Practicality of integrating assessments into the routine respiratory clinic pathway: percentage completing all in-clinic assessments during one routine clinic visit
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.
Time frame
Day 14
Completion of Indirect Calorimetry using a canopy hood or mask
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.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov
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