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Enrolling by invitationNCT07564921Updated May 4, 2026

Nutritional Status and Muscle Function in Ambulatory Multiple Sclerosis Patients With Dysphagia

An observational study in Multiple Sclerosis, Nutrition and Swallowing, sponsored by Sanko University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Sanko University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
34
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to evaluate the relationship between dysphagia severity and indicators of nutritional status and muscle function in ambulatory patients diagnosed with Multiple Sclerosis (MS) who have swallowing difficulties. In patients with MS, the prevalence of swallowing disorders increases with disease duration and greater neurological involvement. Dysphagia may lead to important clinical consequences such as aspiration risk, inadequate oral intake, involuntary weight loss, and reduced quality of life.

Swallowing difficulties negatively affect both the adequacy and safety of nutrition, thereby increasing the risk of malnutrition. In addition, reduced energy and protein intake may lead to a decline in muscle strength and functional capacity.

However, in the MS population, dysphagia, nutritional status, and muscle function are often evaluated separately, and studies that assess these domains together are limited. There is a need for real-world data in ambulatory MS patients, particularly using age-independent nutritional screening tools and functional muscle assessment tests in combination.

This study aims to systematically and multidisciplinary evaluate nutritional status and muscle function in MS patients with dysphagia.

Read the detailed description

This study is a cross-sectional observational research conducted in ambulatory patients diagnosed with Multiple Sclerosis (MS) who experience swallowing difficulties. Participants who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained prior to enrollment.

Demographic and clinical data of the participants (such as age, gender, and disease duration) will be recorded. Swallowing function will be assessed using validated dysphagia screening and/or assessment tools.

Nutritional status will be evaluated using standardized nutritional screening tools and/or anthropometric measurements (such as body weight, height, and body mass index). Muscle function will be assessed using functional measures, including handgrip strength and/or other appropriate muscle performance tests.

The collected data will be statistically analyzed to investigate the relationship between dysphagia severity, nutritional status, and muscle function. No invasive procedures will be performed in this study; only observational and measurement-based assessments will be conducted.

02

Conditions studied

  • Multiple Sclerosis
  • Nutrition
  • Swallowing

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Keywords

  • multiple sclerosis
  • nutrıtıon
  • swallowing
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 34 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Sanko University is the lead sponsor of 52 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

MS patients with swallowing difficulties

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Be 18 years of age or older
  2. Have a diagnosis of multiple sclerosis according to the 2017 Revised McDonald criteria
  3. Have difficulty swallowing (DYMUS >1)
  4. EDSS score must be available in clinical records
  5. Possess sufficient cognitive and physical capacity to participate in the questionnaires and assessments to be administered as part of the study

Exclusion criteria

Exclusion Criteria:

  • 1. A recent acute MS relapse or use of high-dose within the past 4 weeks 2. Acute orthopedic or traumatic conditions that prevent the performance of measurements 3. Severe cognitive impairment that prevents understanding or performing the tests 4. Being pregnant or breastfeeding 5. Presence of active or advanced systemic disease 6. Having any pathology in the cervical region
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
34 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Body weight and height

    These will be measured in accordance with standard anthropometric measurement protocols. Height will be measured using a stadiometer with participants standing in the Frankfurt plane. Body weight will be measured with a calibrated digital scale accurate to 0.1 kg. Body mass index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters.

    Time frame: 2 months

  2. Eating Assessment Tool-10 (EAT-10)

    Developed by Belafsky and colleagues , this is a 10-item self-report scale that assesses the severity of dysphagia as perceived by the patient. Each item is scored on a scale of 0-4, and the total score ranges from 0 to 40. A total score of 3 or higher indicates a clinically significant risk of dysphagia. The validity and reliability of the scale in Turkish were established by Demir and colleagues.

    Time frame: 2 months

  3. Dysphagia in Multiple Sclerosis (DYMUS)

    Dysphagia in Multiple Sclerosis (DYMUS): DYMUS is a 10-item self-administered questionnaire requiring "yes/no" responses, developed to assess symptoms and signs of swallowing difficulties specific to multiple sclerosis (MS) in relation to solid and liquid foods. The validity and reliability study of the Turkish version was conducted by Arslan and colleagues, and it has been demonstrated that the Turkish version is a valid and reliable tool for assessing dysphagia in patients with MS.

    Time frame: 2 months

  4. Yale Swallowing Protocol

    A standardized swallowing screening test developed to assess the risk of aspiration and the safety of oral feeding in individuals with swallowing disorders. The protocol focuses specifically on determining the risk of aspiration during fluid intake and is used as a quick and reliable screening tool in clinical practice. The test consists of a structured procedure requiring the individual to drink approximately 90 mL (3 ounces) of water without interruption.

    Time frame: 2 months

  5. Malnutrition Universal Screening Tool (MUST)

    MUST is a short, practical, and age-independent nutritional screening tool developed to identify the risk of malnutrition in adults. It consists of three components: Body Mass Index (BMI), unintentional weight loss in the past 3-6 months, and the impact of acute illness or inability to eat. Based on the total score, individuals are classified as having low, moderate, or high risk of malnutrition. British Association for Parenteral and Enteral.

    Time frame: 2 months

07

Study locations

1 site
  • Sanko Unıversıtesı
    Gaziantep, şehitkamil 27500, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2026 to primary completion in Apr 2026, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
May 4, 2026
StartActual
Feb 1, 2026
Primary completionActual
Apr 15, 2026
CompletionEst.
May 1, 2026
Last update
May 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07564921
Lead sponsor
Sanko University
Responsible party
Hakan Polat (director, Sanko University) — Principal investigator
First posted
May 4, 2026
Start date
Feb 1, 2026
Primary completion
Apr 15, 2026
Completion
May 1, 2026 (estimated)
Last update
May 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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