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

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Other: lemon extract; Other: cinnamon extract; Other: lemon extract plus eucalyptus extract

• Registration Number: NCT02422576
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Primary Completion: 2017-06-12
• Study Completion: 2017-09-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control + Product 2	lemon extract	Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract)
Control + Product 1	cinnamon extract	Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract)
Control + Product 3	lemon extract plus eucalyptus extract	Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract)

Primary Outcome Measures

Name	Time	Method
Improvement of the safety of the swallowing function, according to Rosenbek's scale	up to15 min after ingredient ingestion	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues	up to15 min after ingredient ingestion	Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues	up to15 min after ingredient ingestion	Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Efficacy of swallowing function-Time to upper oesophageal sphincter opening	up to15 min after ingredient ingestion	Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Efficacy of swallowing function-Time to laryngeal vestibule opening	up to15 min after ingredient ingestion	Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Swallowing safety-Prevalence of penetration	up to15 min after ingredient ingestion	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.
Swallowing safety-Prevalence of aspiration	up to15 min after ingredient ingestion	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.
Efficacy of swallowing function-time to laryngeal vestibule closure	up to15 min after ingredient ingestion	time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Modification of brain physiology response to sensory input:	up to 20 min after ingredient ingestion	Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG.
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).	ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested	using questionnaire
palatability using a questionnaire, assessed during EEG sessions (V3 and V4)	ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested	using questionnaire

Trial Locations

Locations (1)

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain