The Prevalance of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsing Remitting Multiple Sclerosis (RRMS); Malnutrition or Risk of Malnutrition

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 Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Antalya
    • Antalya, Antalya, Turkey (Türkiye), 07100
      • Antalya Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Controls; Healthy Controls
Patients; Patients with Relapsing-Remitting Multiple Sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline
Height as an anthropometric measurement	Height will be measured in meters in both patients with relapsing-remitting multiple sclerosis and healthy controls.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	At baseline

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Chair: Serkan Özben, PhD, Antalya Training And Research Hospital

Publications and helpful links

General Publications

• Lassmann 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.
• Burgos 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.
• 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.
• Matusik 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.
• Schwarz S, Leweling H. Multiple sclerosis and nutrition. Mult Scler. 2005 Feb;11(1):24-32. doi: 10.1191/1352458505ms1119oa.
• Khurana 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): January 3, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: nutritional status; depression; multiple sclerosis; bioelectrical impedance analysis; malnutrition; disability; urinary incontinence; healthy controls; anthropometric measurements; anger; MNA-SF
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Nutrition Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Urinary Incontinence; Multiple Sclerosis; Depression; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 2024-291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No