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

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

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

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.

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