Clinical trial NCT01772888: Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?
Official title: Chewing Efficiency Measured by a Two Colour Chewing Gum Test: a Marker of Insufficient Nutritional Intakes and Percutaneous Gastrostomy (PEG) Necessity in ALS Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis 11
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients participating in the cohort study of the University Hospital Geneva

Brief summary: Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.

Detailed description: Study center: University Hospitals of Geneva Study type: Cohort study with matched controls Study population: 25 ALS patients included in the multidisciplinary cohort study of the University Hospital Geneva between October 2012 and October 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status.

Study duration: Inclusion from October 2012 to October 2016. Follow-up for 3 years.

Study hypothesis: Chewing efficiency, maximum bite and lip force decrease with time in ALS patients and may be a marker of texture adaptation and PEG necessity.

Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.

The secondary aims are to determine, in ALS patients, whether:

* Maximum bite and lip force decrease.
* Chewing efficiency, maximum bite and lip force decrease more in ALS patients with bulbar than with spinal onset.
* Chewing efficiency and bite force correlate with energy intakes, nasofibroscopic assessment, and a validated swallowing questionnaire.
* Saliva volume increases with time and progression of disease and influences masticatory efficiency.
* Saliva volume is associated with nasofibroscopy assessment.

Methods : Every three months, we will perform:

* As part of the ongoing cohort study (already accepted by the Ethical Committee) calculation of energy intakes through a 24h recall, nasofibroscopy, swallowing questionnaire and score of disease severity.
* As part of this study: assessment of dental status at first visit, chewing efficiency test by a with a colour mixing ability test, maximum voluntary bite and lip force, saliva volume and calculation of a 3-day dietary recall instead of a 24h recall.

Statistics: Evolutions with time and between groups, of chewing efficiency, bite and lip force will be assessed by repeated measures ANOVA. Correlations between two continuous variables will be examined by Spearman's correlation coefficients at the different time points. Correlations between a continuous variable and a binary variable (nasofibroscopic assessment) will be explored by logistic regression with mixed effect model.

Eligibility criteria: Inclusion Criteria:

* ALS patients
* \> 18 years
* Participation in the cohort study

Exclusion Criteria:

* Refusal of participating in the cohort study
* Presence of PEG

Primary outcomes:
measure: - Chewing efficiency
timeFrame: 5 years
Secondary outcomes:
measure: Lip force
timeFrame: 5 years
measure: Bite force
timeFrame: 5 years
measure: Calorie and protein intakes
timeFrame: 5 years
measure: Saliva volume
timeFrame: 5 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Laurence Genton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schimmel M, Christou P, Herrmann F, Muller F. A two-colour chewing gum test for masticatory efficiency: development of different assessment methods. J Oral Rehabil. 2007 Sep;34(9):671-8. doi: 10.1111/j.1365-2842.2007.01773.x.
citation: Schimmel M, Leuchter I, Heritier Barras AC, Leles CR, Abou-Ayash S, Viatte V, Esteve F, Janssens JP, Mueller F, Genton L. Oral function in amyotrophic lateral sclerosis patients: A matched case-control study. Clin Nutr. 2021 Aug;40(8):4904-4911. doi: 10.1016/j.clnu.2021.06.022. Epub 2021 Jun 28.