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

Société des Produits Nestlé (SPN)104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Dysphagia

Interventions

cinnamon extractOTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

lemon extractOTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

lemon extract plus eucalyptus extractOTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Mataró

Mataró, Barcelona, Spain

Outcomes

Primary Outcomes

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.