Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. Among the many symptoms, fatigue is very common with a significant impact on quality of life. Also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. We propose to study the link between fatigue and shortcomings encountered in a defined population of MS patients.

Official Title
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Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: Blood sampling
* Other: Gustatory sensitivity test using Taste strips
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 65 years old Expended disability status scale (EDSS) between 0 and 7 Diagnosis of MS according to the revised criteria of McDonald Clinically stable patients in the past 3 months Coverage of the social insurance Informed consent to participate Exclusion Criteria: Cognitive disorders that can hinder answering questionnaires Presence of uncontrolled metabolic disease(s) Malabsorption Patients with a gastrostomy Active cancer under treatment Anorexia Pregnancy or breast feeding Severe psychiatric disorder(s) No informed consent to participate No coverage by the social insurance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis cases<br>All patients will undergo the following interventions Gustatory sensitivity test using Taste strips Blood sampling Questionnaires | Procedure: Blood sampling<br>* A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.<br>Other: Gustatory sensitivity test using Taste strips<br>* 16 Taste Strips impregnated with 4 flavors (sweet, sour, salty, bitter, each flavor present at 4 different concentrations), are offered to the patient one after the other in a so-called pseudorandomized sequence. The task of the patient is to choose one of the following answers: sweet / sour / salty / bitter / no taste. Each correct answer is granted one point. In addition to the impregnated strips, two tasteless strips can be integrated in the examination at any point of time (no point)<br>Other: Questionnaires<br>* Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket): Fatigue (EMIF-SEP) Dysphagia (DYMUS) Food intake (semi-structured questionnaire) Depression (BDI-II) Daily energy expenditure (NAP) Visual analog scale to study quality of sleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status | The objective is to construct and validate a regression model between the scale of fatigue and biological variables | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of sociodemographic variables |  | Baseline | 
| Presence or absence of clinical manifestations |  | Baseline | 
| Level of physical activity and daily energy expenditure |  | Baseline | 
| Assessment of dysphagia according to the score of the Dymus Test |  | Baseline | 
| Score of the taste sensibility test |  | Baseline | 
| Score of the Beck depression inventory test | This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression | Baseline | 
| Score of the visual analog scale for the evaluation of sleep quality |  | Baseline | 
| Score of the Nutrition and Eating Habits Questionnaire |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Fatigue, Nutritional Status, Disability.