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

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

Study Overview

• Status: Completed
• Conditions: Dysphagia
• Intervention / Treatment: Other: cinnamon extract; Other: Thicken Up clear: TUC; Other: lemon extract; Other: lemon extract plus eucalyptus extract

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Hospital de Mataró

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control + Product 1; Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract)	Other: cinnamon extract; acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity); Other: Thicken Up clear: TUC
Active Comparator: Control + Product 2; Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract)	Other: Thicken Up clear: TUC; Other: lemon extract; acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Active Comparator: Control + Product 3; Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract)	Other: Thicken Up clear: TUC; Other: lemon extract plus eucalyptus extract; acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Pere Clavé, Md/PhD, Hospital de Mataró

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 12, 2017
• Study Completion (Actual): September 11, 2017

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 14.13.NRC