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Amyotrophic Lateral Sclerosis (ALS)GOUSLANCT06608004

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

An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyotrophic Lateral Sclerosis (ALS)
What is being tested?
test taking
How many people
60 participants
Where
1 siteFrance
Study dates
12 May 2026to 12 May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with ALS will be referred to the regional reference centre for treatment.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Chu Dijon Bourgogne

    Dijon, 21000

    Marjolaine GEORGES, 0380293772 ext. +33, marjolaine.georges@chu-dijon.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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

Being tested
test taking
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • test takingOther

    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 groups in NCT06608004
Study groupRoleWhat they receive
patientALS patients referred to the ALS Reference Centre at Dijon University Hospital and Lyon University Hospital
Receives: Other: test taking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, on average of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start12 May 2026
  3. Primary completion12 May 2029 (estimated)
  4. Study completion12 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608004
Sponsor's protocol ID
GEORGES ARSLA 2021
Acronym
GOUSLA
Status last verified
May 2026
First submitted
19 Sep 2024
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Centre Hospitalier Universitaire Dijon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marjolaine GEORGES (0380293772 ext. +33, marjolaine.georges@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The measurement of implicit wanting (time frame: Through study completion, on average of 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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