Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Influence of Olfacto-gustatory Sensoriality on the Nutritional Status of Patients With Amyotrophic Lateral Sclerosis

NCT06608004 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-05-12
Last updated
2026-05-15

Condition(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Investigational drug(s) / intervention(s)

test taking

test taking: Measurement 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Inclusion criteria\*: * 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 Exclusion Criteria: * 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) * Patients who have stopped smoking for less than 1 month * Patients with severe bulbar involvement from the outset, preventing swallowing, patients with aphagia or patients eating exclusively via a gastrostomy * Patient with severe diaphragmatic impairment requiring NIV from the outset * Person not affiliated to or not benefiting from a social security scheme * Person under legal protection (curatorship, guardianship) * Persons subject to a legal protection measure * Pregnant women, women in labour or breastfeeding mothers * An adult who is incapable or unable to give consent * Minors

Primary outcome measure(s)

  • The measurement of implicit wanting — Through study completion, on average of 12 months
    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.

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourgogne Dijon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608004 on ClinicalTrials.gov ↗ ← All trials in France