Relapsing Remitting Multiple Sclerosis (RRMS)NCT07497126
The Prevalance of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis
An observational study of Relapsing Remitting Multiple Sclerosis (RRMS) and Malnutrition or Risk of Malnutrition, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to determine the prevalence of malnutrition in patients with relapsing-remitting multiple sclerosis and to evaluate its association with disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition
- How many people
- 169 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2024to 15 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study population will consist of adults aged 18 years or older. The patient group will include individuals with relapsing-remitting multiple sclerosis who are followed in the neurology outpatient clinic of Antalya Training and Research Hospital and meet the predefined inclusion and exclusion criteria. A healthy control group of adult volunteers without multiple sclerosis will be recruited for comparison.
Who may be able to join
- Age 18 years or older
- Diagnosis of relapsing-remitting multiple sclerosis for the patient group
- Absence of another medical condition that markedly impairs walking, such as severe cardiovascular disease, respiratory disease, or major orthopedic conditions
- Healthy volunteers willing to participate as controls
- Written informed consent provided
Who cannot join
- EDSS score ≥7 in the relapsing-remitting multiple sclerosis group
- Multiple sclerosis relapse during the last 30 days
- Systemic glucocorticoid treatment during the last 30 days
- History of musculoskeletal disease
- History of neuromuscular junction disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Antalya, 07100
About this study
Official title: The Prevalence of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis: A Prospective Cross-Sectional Observational Study
This prospective observational study aims to determine the prevalence of malnutrition in patients with relapsing-remitting multiple sclerosis and to evaluate its association with disability. Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form, and body composition will be evaluated with bioelectrical impedance analysis and anthropometric measurements. The study will also assess urinary incontinence, depression, and anger-related features, and compare the findings with those of healthy controls.
Read the detailed description
Multiple sclerosis is a chronic inflammatory and demyelinating disease of the central nervous system that may lead to disability, reduced mobility, bladder dysfunction, depression, and impaired quality of life. In the early stages of the disease, overweight and obesity may be common, whereas with disease progression, malnutrition and cachexia may become more prominent. Malnutrition may contribute to muscle loss, reduced mobility, worsening functional status, and increased clinical burden.
This single-center, hospital-based, prospective cross-sectional observational study will be conducted in the multiple sclerosis and neurology outpatient clinics of Antalya Training and Research Hospital. Adult patients diagnosed with relapsing-remitting multiple sclerosis and healthy controls will be included. Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form. Body composition and anthropometric parameters, including waist-to-height ratio, waist-to-hip ratio, body fat percentage, fat mass, fat-free mass, total body water, and predicted muscle mass, will be evaluated using bioelectrical impedance analysis and standard anthropometric measurements. Disability in the patient group will be assessed with the Expanded Disability Status Scale. Depression, anger-related characteristics, and urinary incontinence profiles will also be evaluated using structured questionnaires and validated scales.
The study is designed to investigate the prevalence of malnutrition in relapsing-remitting multiple sclerosis, compare nutritional and related clinical parameters with healthy controls, and examine the relationship between malnutrition, body composition, and disability.
- Keywords
- malnutrition, disability, nutritional status, MNA-SF, bioelectrical impedance analysis, anthropometric measurements, multiple sclerosis, urinary incontinence, depression, anger, healthy controls
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Malnutrition, Multiple Sclerosis, Urinary Incontinence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Relapsing-Remitting Multiple Sclerosis | |
| Controls | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form
Malnutrition status and risk of malnutrition will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF) in patients with relapsing-remitting multiple sclerosis and healthy controls. MNA-SF is a screening tool with a total score ranging from 0 to 14. Lower scores indicate worse nutritional status. Scores from 12 to 14 indicate normal nutritional status, scores from 8 to 11 indicate risk of malnutrition, and scores from 0 to 7 indicate malnutrition.
The relationships between MNA-SF and anthropometric, body composition, depressive and anger-related variables will also be evaluated.
Measured: At baseline
Secondary outcomes (20)
Expanded Disability Status Scale score
Disability severity will be assessed in patients with Multiple Sclerosis (MS) using the Expanded Disability Status Scale (EDSS), which ranges from 0 to 10 in 0.5-point increments. Higher scores indicate worse disability. A score of 0 indicates normal neurological status, and a score of 10 indicates death due to MS.
The relationships between disability severity and anthropometric, body composition, depressive, anger-related, and urinary incontinence-related variables will also be evaluated.
Measured: At baseline
Height as an anthropometric measurement
Height will be measured in meters in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Body weight as an anthropometric measurement
Body weight will be measured in kilograms in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Body mass index as an anthropometric measurement
Body mass index (BMI) will be calculated in kilograms per square meter (kg/m²) using measured body weight and height in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Waist circumference as an anthropometric measurement
Waist circumference will be measured in centimeters in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Hip circumference as an anthropometric measurement
Hip circumference will be measured in centimeters in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Waist-to-height ratio as an anthropometric measurement
Waist-to-height ratio (WHtR) will be calculated using waist circumference and height measurements in both patients with relapsing-remitting multiple sclerosis and healthy controls. Higher values indicate greater central adiposity.
Measured: At baseline
Waist-to-hip ratio as an anthropometric measurement
Waist-to-hip ratio (WHR) will be calculated using waist circumference and hip circumference measurements in both patients with relapsing-remitting multiple sclerosis and healthy controls.
Measured: At baseline
Fat mass (kg)
Fat mass (FM) will be measured in kilograms using the TANITA® MC-180MA Bioelectric Impedance Analyser device in both patients with RRMS and healthy controls. Bioelectrical impedance analysis will be performed 2 hours after a meal, following 5 minutes of rest, with participants standing still on the device with bare hands and feet.
Measured: At baseline
Fat mass (%)
Fat mass percentage will be derived from fat mass relative to body weight and expressed as a percentage in both patients with RRMS and healthy controls. Measurements will be obtained using the TANITA® MC-180MA Bioelectric Impedance Analyser. Bioelectrical impedance analysis will be performed 2 hours after a meal, following 5 minutes of rest, with participants standing still on the device with bare hands and feet.
Measured: At baseline
Fat-free mass (kg)
Fat-free mass (FFM) will be measured in kilograms using the TANITA® MC-180MA Bioelectric Impedance Analyser in both patients with RRMS and healthy controls. Bioelectrical impedance analysis will be performed 2 hours after a meal, following 5 minutes of rest, with participants standing still on the device with bare hands and feet.
Measured: At baseline
Total body water (kg)
Total body water (TBW) will be measured in kilograms using the TANITA® MC-180MA Bioelectric Impedance Analyser in both patients with RRMS and healthy controls. Bioelectrical impedance analysis will be performed 2 hours after a meal, following 5 minutes of rest, with participants standing still on the device with bare hands and feet.
Measured: At baseline
Predicted muscle mass (kg)
Predicted muscle mass (PMM) will be measured in kilograms using the TANITA® MC-180MA Bioelectric Impedance Analyser in both patients with RRMS and healthy controls. Bioelectrical impedance analysis will be performed 2 hours after a meal, following 5 minutes of rest, with participants standing still on the device with bare hands and feet.
Measured: At baseline
Beck Depression Inventory score
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which ranges from 0 to 63. Higher scores indicate more severe depressive symptoms. Commonly used score ranges are 0-9 for minimal depression, 10-16 for mild depression, 17-29 for moderate depression, and 30-63 for severe depression.
Measured: At baseline
Trait anger score
Anger disposition will be assessed using the Trait Anger subscale of the State-Trait Anger Scale (STAS). Scores range from 10 to 40, with higher scores indicating greater trait anger.
Measured: At baseline
Anger-in score
Suppressed anger will be assessed using the Anger In subscale of the State-Trait Anger Scale (STAS). Scores range from 8 to 32, with higher scores indicating a greater tendency to suppress anger.
Measured: At baseline
Anger-out score
Outward expression of anger will be assessed using the Anger Out subscale of the State-Trait Anger Scale (STAS). Scores range from 8 to 32, with higher scores indicating a greater tendency to express anger outwardly.
Measured: At baseline
Anger control score
Anger control will be assessed using the Anger Control subscale of the State-Trait Anger Scale (STAS). Scores range from 8 to 32, with higher scores indicating better anger control.
Measured: At baseline
Urinary incontinence symptom-based subtype classification
Urinary incontinence symptoms will be assessed using semi-structured symptom-based urinary incontinence screening questionnaires designed to identify stress, urge, and overflow incontinence patterns. The questionnaires include symptom-oriented items with response options such as yes, no, and "more than half of the time," and additional questions on urinary frequency, nocturia, leakage frequency, and leakage amount where applicable. Participants will be classified according to the predominant symptom pattern identified from the questionnaire responses as stress, urge, or overflow urinary incontinence.
Measured: At baseline
Correlation between EDSS score and MNA-SF
The correlation between disability severity, as measured by EDSS, and nutritional status as measured by MNA-SF will be evaluated in patients with RRMS.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start4 Nov 2024
- Primary completion3 Jan 2026
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple Sclerosis (RRMS)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ozan Arslan, Antalya Training and Research Hospital
- Investigators
- Serkan Özben, PhD, Study chair, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497126
- Sponsor's protocol ID
- 2024-291
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pilutti LA, Motl RW. Body Mass Index Underestimates Adiposity in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Mar;97(3):405-12. doi: 10.1016/j.apmr.2015.09.014. Epub 2015 Oct 9.
PubMed 26440775Matusik E, Augustak A, Durmala J. Functional Mobility and Basic Motor Skills in Patients with Multiple Sclerosis and Its Relation to the Anthropometrical Status and Body Composition Parameters. Medicina (Kaunas). 2019 Dec 4;55(12):773. doi: 10.3390/medicina55120773.
PubMed 31817216Schwarz S, Leweling H. Multiple sclerosis and nutrition. Mult Scler. 2005 Feb;11(1):24-32. doi: 10.1191/1352458505ms1119oa.
PubMed 15732263Burgos R, Breton I, Cereda E, Desport JC, Dziewas R, Genton L, Gomes F, Jesus P, Leischker A, Muscaritoli M, Poulia KA, Preiser JC, Van der Marck M, Wirth R, Singer P, Bischoff SC. ESPEN guideline clinical nutrition in neurology. Clin Nutr. 2018 Feb;37(1):354-396. doi: 10.1016/j.clnu.2017.09.003. Epub 2017 Sep 22.
PubMed 29274834Khurana SR, Bamer AM, Turner AP, Wadhwani RV, Bowen JD, Leipertz SL, Haselkorn JK. The prevalence of overweight and obesity in veterans with multiple sclerosis. Am J Phys Med Rehabil. 2009 Feb;88(2):83-91. doi: 10.1097/PHM.0b013e318194f8b5.
PubMed 19169174Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
PubMed 17388952
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis: A Prospective Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07497126
- Acronym / sponsor ID
- 2024-291
- Keywords
- malnutrition, disability, nutritional status, MNA-SF, bioelectrical impedance analysis, anthropometric measurements, multiple sclerosis, urinary incontinence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 27 Mar 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.
This prospective observational study aims to determine the prevalence of malnutrition in patients with relapsing-remitting multiple sclerosis and to evaluate its association with disability. Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form, and body composition will be evaluated with bioelectrical impedance analysis and anthropometric measurements. The study will also assess urinary incontinence, depression, and anger-related features, and compare the findings with those of healthy controls.
Detailed description
Multiple sclerosis is a chronic inflammatory and demyelinating disease of the central nervous system that may lead to disability, reduced mobility, bladder dysfunction, depression, and impaired quality of life. In the early stages of the disease, overweight and obesity may be common, whereas with disease progression, malnutrition and cachexia may become more prominent. Malnutrition may contribute to muscle loss, reduced mobility, worsening functional status, and increased clinical burden.
This single-center, hospital-based, prospective cross-sectional observational study will be conducted in the multiple sclerosis and neurology outpatient clinics of Antalya Training and Research Hospital. Adult patients diagnosed with relapsing-remitting multiple sclerosis and healthy controls will be included. Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form. Body composition and anthropometric parameters, including waist-to-height ratio, waist-to-hip ratio, body fat percentage, fat mass, fat-free mass, total body water, and predicted muscle mass, will be evaluated using bioelectrical impedance analysis and standard anthropometric measurements. Disability in the patient group will be assessed with the Expanded Disability Status Scale. Depression, anger-related characteristics, and urinary incontinence profiles will also be evaluated using structured questionnaires and validated scales.
The study is designed to investigate the prevalence of malnutrition in relapsing-remitting multiple sclerosis, compare nutritional and related clinical parameters with healthy controls, and examine the relationship between malnutrition, body composition, and disability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with Relapsing-Remitting Multiple Sclerosis |
| Controls | – | –Healthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study population will consist of adults aged 18 years or older. The patient group will include individuals with relapsing-remitting multiple sclerosis who are followed in the neurology outpatient clinic of Antalya Training and Research Hospital and meet the predefined inclusion and exclusion criteria. A healthy control group of adult volunteers without multiple sclerosis will be recruited for comparison.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Diagnosis of relapsing-remitting multiple sclerosis for the patient group
- Absence of another medical condition that markedly impairs walking, such as severe cardiovascular disease, respiratory disease, or major orthopedic conditions
- Healthy volunteers willing to participate as controls
- Written informed consent provided
Key exclusion criteria (5 listed)
- EDSS score ≥7 in the relapsing-remitting multiple sclerosis group
- Multiple sclerosis relapse during the last 30 days
- Systemic glucocorticoid treatment during the last 30 days
- History of musculoskeletal disease
- History of neuromuscular junction disease
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
Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form
Time frame: At baseline
Malnutrition status and risk of malnutrition will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF) in patients with relapsing-remitting multiple sclerosis and healthy controls. MNA-SF is a screening tool with a total score ranging from 0 to 14. Lower scores indicate worse nutritional status. Scores from 12 to 14 indicate normal nutritional status, scores from 8 to 11 indicate risk of malnutrition, and scores from 0 to 7 indicate malnutrition. The relationships between MNA-SF and anthropometric, body composition, depressive and anger-related variables will also be evaluated.
20 secondary outcomes
Expanded Disability Status Scale score
Time frame: At baseline
Height as an anthropometric measurement
Time frame: At baseline
Body weight as an anthropometric measurement
Time frame: At baseline
Body mass index as an anthropometric measurement
Time frame: At baseline
Waist circumference as an anthropometric measurement
Time frame: At baseline
Hip circumference as an anthropometric measurement
Time frame: At baseline
Waist-to-height ratio as an anthropometric measurement
Time frame: At baseline
Waist-to-hip ratio as an anthropometric measurement
Time frame: At baseline
Fat mass (kg)
Time frame: At baseline
Fat mass (%)
Time frame: At baseline
Fat-free mass (kg)
Time frame: At baseline
Total body water (kg)
Time frame: At baseline
Predicted muscle mass (kg)
Time frame: At baseline
Beck Depression Inventory score
Time frame: At baseline
Trait anger score
Time frame: At baseline
Anger-in score
Time frame: At baseline
Anger-out score
Time frame: At baseline
Anger control score
Time frame: At baseline
Urinary incontinence symptom-based subtype classification
Time frame: At baseline
Correlation between EDSS score and MNA-SF
Time frame: At baseline
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 27 Mar 2026.
- Background: PubMed 26440775Pilutti LA, Motl RW. Body Mass Index Underestimates Adiposity in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Mar;97(3):405-12. doi: 10.1016/j.apmr.2015.09.014. Epub 2015 Oct 9.
- Background: PubMed 31817216Matusik E, Augustak A, Durmala J. Functional Mobility and Basic Motor Skills in Patients with Multiple Sclerosis and Its Relation to the Anthropometrical Status and Body Composition Parameters. Medicina (Kaunas). 2019 Dec 4;55(12):773. doi: 10.3390/medicina55120773.
- Background: PubMed 15732263Schwarz S, Leweling H. Multiple sclerosis and nutrition. Mult Scler. 2005 Feb;11(1):24-32. doi: 10.1191/1352458505ms1119oa.
- Background: PubMed 29274834Burgos R, Breton I, Cereda E, Desport JC, Dziewas R, Genton L, Gomes F, Jesus P, Leischker A, Muscaritoli M, Poulia KA, Preiser JC, Van der Marck M, Wirth R, Singer P, Bischoff SC. ESPEN guideline clinical nutrition in neurology. Clin Nutr. 2018 Feb;37(1):354-396. doi: 10.1016/j.clnu.2017.09.003. Epub 2017 Sep 22.
- Background: PubMed 19169174Khurana SR, Bamer AM, Turner AP, Wadhwani RV, Bowen JD, Leipertz SL, Haselkorn JK. The prevalence of overweight and obesity in veterans with multiple sclerosis. Am J Phys Med Rehabil. 2009 Feb;88(2):83-91. doi: 10.1097/PHM.0b013e318194f8b5.
- Background: PubMed 17388952Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Serkan Özben, PhD study chair
Antalya Training and Research Hospital
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 Relapsing Remitting Multiple Sclerosis (RRMS) and Malnutrition or Risk of Malnutrition, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form (time frame: At baseline). 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 NCT07497126, which also lists 6 linked publications.
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 27 Mar 2026.