Amyotrophic Lateral Sclerosis (ALS)MET-MNDNCT07851714
Metabolism and Nutrition in MND
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Motor Neurone Disease (MND), run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Motor Neurone Disease (MND)
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital outpatient department
Who may be able to join
- Adult MND patients aged 18 years or over at the time of giving consent.
- Newly referred to the specialist respiratory service for assessment
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London
Angela Reddy, +442071888070, angelareddy@nhs.net
About this study
Official title: An Observational Study of Metabolism and Nutrition in Motor Neurone Disease (MND): Understanding Determinants of Weight Loss
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Nutrition, Weight loss, metabolic rate, indirect calorimetry
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 through Day 8. Day 1: single study visit. Days 2-8: seven days following the visit for diary completion
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.
Measured: From Day 1 through Day 8.
Secondary outcomes (6)
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.
Measured: From Day 1 through Day 8
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Number of Days Completed in the 7-Day Food Diary
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.
Measured: Day 2-8
Participant Responses to the DEXA Acceptability Questions
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Radcliffe, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851714
- Sponsor's protocol ID
- Guys and St Thomas' NHS
- Acronym
- MET-MND
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. British Thoracic Society Standards of Care Committee. (2002). 'Non-invasive ventilation in acute respiratory failure', Thorax, 57:192-211. doi: 10.1136/thorax.57.3.192. PMID: 11867822; PMCID: PMC1746282. 2. Cedarbaum, J.M., Stambler, N., Malta, E., et., (1999). The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). Journal of the Neurological Sciences, 169(1-2), pp.13-21. https://doi.org/10.1016/S0022-510X(99)00210-5 3. MNDA (2023) Motor Neurone Disease Association Key messages and core information. Available at https://www.mndassociation.org/sites/default/files/2023-05/MND%20Association%20key%20messages%20updated%20May%202023.pdf (Accessed: 6/8/2025). 4. National Institute of Neurological Disorders and Stroke (NINDS). [online, accessed 28 November 2025]. Last updated 26 March 2025. Available from: https://www.ninds.nih.gov/health-information/disorders/motor-neuron-diseases?search-term=MND 5. MND Association. [online, accessed 28 November 2025]. Available from: MND Association key messages infographic May 2023.pdf 6. Cederholm, T. et al. ESPEN guidelines on definitions and terminology of clinical nutrition Clinical Nutrition, Volume 36, Issue 1, 49 - 64. 6a. The British Association for Parenteral and Enteral Nutrition (BAPEN). [online, accessed 27 November 2025]. 7. Nutrition Support for Adults (2006). NICE guideline CG32. Last updated 4 August 2017. 8. Stratton RJ, Smith TS and Gabe SG. 2018. Managing malnutrition to improve lives and save money. [online, accessed 27 November 2025]. Available from: https://www.bapen.org.uk/pdfs/reports/mag/managing-malnutrition.pdf 9. Muscaritoli M, Kushta I, Molfino A, et al. Nutritional and metabolic support in patients with amyotrophic lateral sclerosis. Nutrition. 2012; 28:959-66. 10. Zarco-Martín MT, Freire C, Andreo-López MC, et al. Malnutrition in Amyotrophic Lateral Sclerosis: Insights from Morphofunctional Assessment and Global L
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Metabolism and Nutrition in Motor Neurone Disease (MND): Understanding Determinants of Weight Loss
- ClinicalTrials.gov ID
- NCT07851714
- Acronym / sponsor ID
- MET-MND / Guys and St Thomas' NHS
- Keywords
- Nutrition, Weight loss, metabolic rate, indirect calorimetry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital outpatient department
Key inclusion criteria (2 listed)
- Adult MND patients aged 18 years or over at the time of giving consent.
- Newly referred to the specialist respiratory service for assessment
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of planned metabolic, nutritional and body composition assessments completed
Time frame: 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
Time frame: 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.
6 secondary outcomes
Participant acceptability and tolerability: number of participants unable to complete each assessment due to acceptability or tolerability of study assessments
Time frame: From Day 1 through Day 8
Time taken to complete each in clinic study assessment
Time frame: Day 1
Practicality of integrating assessments into the routine respiratory clinic pathway: percentage completing all in-clinic assessments during one routine clinic visit
Time frame: Day 1
Completion of Indirect Calorimetry using a canopy hood or mask
Time frame: Day 1
Number of Days Completed in the 7-Day Food Diary
Time frame: Day 2-8
Participant Responses to the DEXA Acceptability Questions
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background1. British Thoracic Society Standards of Care Committee. (2002). 'Non-invasive ventilation in acute respiratory failure', Thorax, 57:192-211. doi: 10.1136/thorax.57.3.192. PMID: 11867822; PMCID: PMC1746282. 2. Cedarbaum, J.M., Stambler, N., Malta, E., et., (1999). The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). Journal of the Neurological Sciences, 169(1-2), pp.13-21. https://doi.org/10.1016/S0022-510X(99)00210-5 3. MNDA (2023) Motor Neurone Disease Association Key messages and core information. Available at https://www.mndassociation.org/sites/default/files/2023-05/MND%20Association%20key%20messages%20updated%20May%202023.pdf (Accessed: 6/8/2025). 4. National Institute of Neurological Disorders and Stroke (NINDS). [online, accessed 28 November 2025]. Last updated 26 March 2025. Available from: https://www.ninds.nih.gov/health-information/disorders/motor-neuron-diseases?search-term=MND 5. MND Association. [online, accessed 28 November 2025]. Available from: MND Association key messages infographic May 2023.pdf 6. Cederholm, T. et al. ESPEN guidelines on definitions and terminology of clinical nutrition Clinical Nutrition, Volume 36, Issue 1, 49 - 64. 6a. The British Association for Parenteral and Enteral Nutrition (BAPEN). [online, accessed 27 November 2025]. 7. Nutrition Support for Adults (2006). NICE guideline CG32. Last updated 4 August 2017. 8. Stratton RJ, Smith TS and Gabe SG. 2018. Managing malnutrition to improve lives and save money. [online, accessed 27 November 2025]. Available from: https://www.bapen.org.uk/pdfs/reports/mag/managing-malnutrition.pdf 9. Muscaritoli M, Kushta I, Molfino A, et al. Nutritional and metabolic support in patients with amyotrophic lateral sclerosis. Nutrition. 2012; 28:959-66. 10. Zarco-Martín MT, Freire C, Andreo-López MC, et al. Malnutrition in Amyotrophic Lateral Sclerosis: Insights from Morphofunctional Assessment and Global L
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gillian Radcliffe study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Motor Neurone Disease (MND), run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Reddy (+442071888070, angelareddy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of planned metabolic, nutritional and body composition assessments completed (time frame: From Day 1 through Day 8. Day 1: single study visit. Days 2-8: seven days following the visit for diary completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07851714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.