About this trial
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterised by progressive diffuse muscular paralysis due to the inexorable loss of motor neurons in the primary motor cortex, the corticospinal tract, the brain stem and the spinal cord.
Over the course of the disease, when the phrenic motor neurons are involved, diaphragmatic weakness develops, leading to restrictive respiratory failure, which is the main cause of morbidity and mortality. Non-invasive ventilation (NIV) compensates for diaphragm failure and corrects the associated symptoms, and has been shown to prolong patient survival and improve quality of life.
Undernutrition is another recognised prognostic factor. Several mechanisms have been described, foremost of which are a state of hypermetabolism and a reduction in food intake secondary to chewing difficulties, dysphagia, a loss of dexterity in the upper limbs, a disturbance in salivary secretion or psychological disorders. In addition, diaphragmatic dysfunction plays a direct role in the onset of undernutrition, as compensatory contraction of the accessory neck muscles increases resting energy expenditure.
However, the hedonic sensations triggered by a meal play a role in controlling food intake beyond the simple energy balance between calorie intake and energy expenditure. Olfacto-gustatory sensoriality could therefore play a role in the nutritional status of patients suffering from ALS.
Diaphragmatic dysfunction may also influence nutritional status by other mechanisms. For example, the reduction in inspiratory capacity associated with diaphragmatic insufficiency reduces olfaction in a group of tetraplegic patients. Central sensory impairment could exacerbate this phenomenon. Although it is conventionally considered that there are no sensory manifestations during the course of ALS, minor but diffuse abnormalities of the nerves and sensory action potentials have been observed. A central alteration in olfacto-gustatory sensoriality could be part of the neurological manifestations of ALS. In addition, olfactory deficits occur in other neuromuscular diseases with central involvement, such as myasthenia, Parkinson\'s or Alzheimer\'s disease, in the absence of concomitant cognitive or diaphragmatic impairment.
Our hypothesis is that impaired olfacto-gustatory function favours the onset of undernutrition in ALS.
Current nutritional management consists of ensuring adequate calorie intake by prescribing oral food supplements or inserting a gastrostomy. Taking personalised account of food preferences during dietary advice or of a potential olfacto-gustatory deficit, by reinforcing smells or tastes during food consumption, would be an interesting additional therapeutic avenue for improving patients\' nutritional status, quality of life and prognosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Incident cases of definite or probable ALS according to El-Escorial criteria (3) followed up at the participating regional centre of competence
Patient aged over 18
Patient fluent in French
Patient having given oral consent
Disqualifiers
Patients with an acute infection undergoing antibiotic treatment at the time of inclusion
Patients with psychiatric, cognitive or neurological disorders making it impossible to assess food preferences
Patient with a known food allergy
Patients with excessive alcohol consumption (≥ 10 standard drinks per week)
Trial population
Patients with ALS will be referred to the regional reference centre for treatment.
Trial design
Cohort
Prospective
Treatments tested in this trial
test taking
Other interventionMeasurement of VAS for sensation of hunger, LFQP-France test, 24-hour semi-quantitative dietary recall, Assessment of energy expenditure linked to physical activity using the IPAQ (International Physical Activity Questionnaire) (only at inclusion), Screening for undernutrition risk factors using the SSQ (Social Support Questionnaire) (only at inclusion), Measurement of body composition by impedancemetry, Measurement of isometric grip strength by handgrip test, Measurement of quality of life (SF36), Study of olfacto-gustatory sensoriality (olfaction via the Sniffin\' Sticks test, gustation via lingual application of impregnated strips and AHSP self-questionnaire) (carried out every other visit) and Measurement of gustatory evoked potentials in response to sugar.
Treatment groups
Trial outcomes
Primary outcomes
The measurement of implicit wanting
It is calculated for each food category (sweet-poor-fat, sweet-rich-fat, salty-poor-fat and salty-rich-fat) using the Leeds Food Preference Questionnaire (LFQP-France), which measures food preferences. This is a standardised computerised test (32), adapted to French cultural habits. It consists of presenting patients with photos of foods rich in carbohydrates, proteins or lipids.
Sponsors and contacts
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