Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-06-09

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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis cases

All patients will undergo the following interventions

* Gustatory sensitivity test using Taste strips
* Blood sampling
* Questionnaires

Blood sampling

Intervention Type PROCEDURE

A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.

Gustatory sensitivity test using Taste strips

Intervention Type OTHER

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)

Questionnaires

Intervention Type OTHER

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

Interventions

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Blood sampling

A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.

Intervention Type PROCEDURE

Gustatory sensitivity test using Taste strips

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)

Intervention Type OTHER

Questionnaires

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No