NCT02422576

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
OTHER	cinnamon extract	acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHER	lemon extract	acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHER	lemon extract plus eucalyptus extract	acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
OTHER	Thicken Up clear: TUC

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-12
• Completion: 2017-09-11
• First posted: 2015-04-21
• Last updated: 2017-10-26

Locations

1 site across 1 country: Spain