ThickenUp® Gel Express for Patients With Dysphagia
- Conditions
- Dysphagia, Esophageal
- Interventions
- Dietary Supplement: ThickenUp® Gel Express
- Registration Number
- NCT04741581
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.
- Detailed Description
ThickenUp® Gel Express for Patients With Dysphagia ("Hydra-01 Study"): Effect on Swallowing Function as Assessed by a Videofluoroscopy (VFS) One Day Study With Bolus of Various Viscosities (Study Part 1) and Followed, in a Subset of Patients, by a United Kingdom Advisory Committee on Borderline Substances (UK ACBS) Acceptability 14 Days Study Combined With an Exploratory Hydration Assessment Study at a Prescribed Viscosity (Study Part 2).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Thicken up ThickenUp® Gel Express Assess the effect of ThickenUp® Gel Express at increasing viscosities (slightly thick, nectar, honey, and pudding) on swallowing function compared to water using VFS (N=100), in patients affected by Oropharyngeal dysphagia (OD).
- Primary Outcome Measures
Name Time Method The United Kingdom Advisory Committee on Borderline Substances (UK ACBS) 14 days Part 2
Penetration-Aspiration Score (PAS) 1 day Part 1 -Bolus penetration into the laryngeal vestibule (PAS Score): the maximum PAS score across the different boluses assessed during videofluoroscopic (VFS) recording.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Mataró
🇪🇸Mataró, Spain