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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422576
• Other study ID #: 14.13.NRC
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: October 25, 2017
• Start date: March 2015
• Est. completion date: September 11, 2017

Study information

• Verified date: October 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 11, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de Mataró	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Swallowing safety-Prevalence of aspiration	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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