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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control + Product 1 | Active Comparator | Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract) |
|
| Control + Product 2 | Active Comparator | Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract) |
|
| Control + Product 3 | Active Comparator | Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cinnamon extract | Other | acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pere Clavé, Md/PhD | Hospital de Mataro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| C000713347 | lemon balm leaf extract |
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| lemon extract | Other | acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) |
|
| lemon extract plus eucalyptus extract | Other | acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) |
|
| Thicken Up clear: TUC | Other |
|
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 |
| D010038 | Otorhinolaryngologic Diseases |