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

NCT07497126 | Active Not Recruiting

• 1 other identifier: 2024-291
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malnutrition or Risk of Malnutrition; Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

malnutrition; disability; nutritional status; MNA-SF; bioelectrical impedance analysis; anthropometric measurements; multiple sclerosis; urinary incontinence; depression; anger; healthy controls

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Expanded Disability Status Scale score

  At baseline

• Height as an anthropometric measurement

  At baseline

• Body weight as an anthropometric measurement

  At baseline

• Body mass index as an anthropometric measurement

  At baseline

• Waist circumference as an anthropometric measurement

  At baseline

Study Arms (2)

Patients

Patients with Relapsing-Remitting Multiple Sclerosis

Controls

Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26440775 BACKGROUND

• 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.

  PMID: 31817216 BACKGROUND

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

  PMID: 15732263 BACKGROUND

• 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.

  PMID: 29274834 BACKGROUND

• 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.

  PMID: 19169174 BACKGROUND

• 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.

  PMID: 17388952 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Malnutrition; Multiple Sclerosis; Urinary Incontinence; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Serkan Özben, PhD

  Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: November 4, 2024
• Primary Completion: January 3, 2026
• Study Completion: April 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)