Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia

Study Overview
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Brief Summary
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Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.

Detailed Description
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The trial will be double-blind, randomized, monocentric, and interventional with a hybrid design. The subjects will be randomized to one of the three parallel active ingredient groups. Products will be compared versus control (Thicken Up Clear - nectar viscosity), which adds a part of cross over within the design. The total sample size is 84 enrolled subjects. Patients will be males and females aged 55+ with mild proven dysphagia.

Official Title
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Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia

Conditions
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Dysphagia

Intervention / Treatment
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* Other: cinnamon extract
* Other: lemon extract
* Other: lemon extract plus eucalyptus extract
* Other: Thicken Up clear: TUC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 55+ Patients showing impaired safety of the deglutition during the V-VST (volume - viscosity swallow test): Cough oxygen desaturation ≥3% or voice change. Neurodegenerative or ischemic/hemorrhagic cerebral cause (stroke) or elderly subjects Exclusion Criteria: Patients radiated for treatment of head and neck cancer Idiosyncrasis Allergy to food or medication, especially contrast products (iodine) Major respiratory disease needing oxygen as standard treatment. Any major and relevant abdominal, head and neck, or chest surgery within the three months preceding the study. Have a high alcohol consumption (more than 2 drinks/day) Subject who cannot be expected to comply with the study procedures, including consuming the test products. Currently participating or having participated in another clinical trial during the month preceding the study Patients with relevant mucosal damage or with in-mouth irritation Patients with pacemaker or electrode implants Epileptic patients

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control + Product 1<br>Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract) | Other: cinnamon extract<br>* acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)<br>Other: Thicken Up clear: TUC<br> <br> |
| Active Comparator: Control + Product 2<br>Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract) | Other: lemon extract<br>* acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)<br>Other: Thicken Up clear: TUC<br> <br> |
| Active Comparator: Control + Product 3<br>Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract) | Other: lemon extract plus eucalyptus extract<br>* acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)<br>Other: Thicken Up clear: TUC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the safety of the swallowing function, according to Rosenbek's scale | The maximum PAS score across the different boluses (5, 10 and 20 ml) during nectar series (with and without active ingredient) assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing safety-Prevalence of penetration | the prevalence of penetration in the population according to Rosenbek's PAS (scores of 2-5) , assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Swallowing safety-Prevalence of aspiration | the prevalence of aspiration in the population according to Rosenbek's PAS (scores of 6-8), assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues | Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues | Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Efficacy of swallowing function-Time to upper oesophageal sphincter opening | Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Efficacy of swallowing function-Time to laryngeal vestibule opening | Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Efficacy of swallowing function-time to laryngeal vestibule closure | time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition. | up to15 min after ingredient ingestion | 
| Modification of brain physiology response to sensory input: | Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG. | up to 20 min after ingredient ingestion | 
| Tolerability to the products (gastrointestinal comfort) using a questionnaire, assessed during EEG sessions (V3 and V4) to avoid capturing side effects of the contrast agent (as nausea). | using questionnaire | ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested | 
| palatability using a questionnaire, assessed during EEG sessions (V3 and V4) | using questionnaire | ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested |