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

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cinnamon extract
lemon extract
lemon extract plus eucalyptus extract
Thicken Up clear: TUC
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control + Product 1

Control + Product 2

Control + Product 3

Arm Description

Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract)

Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract)

Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Efficacy of swallowing function-Time to laryngeal vestibule opening
Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Efficacy of swallowing function-time to laryngeal vestibule closure
time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Modification of brain physiology response to sensory input:
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).
using questionnaire
palatability using a questionnaire, assessed during EEG sessions (V3 and V4)
using questionnaire

Full Information

First Posted
March 24, 2015
Last Updated
October 25, 2017
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02422576
Brief Title
Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
Official Title
Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
September 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control + Product 1
Arm Type
Active Comparator
Arm Description
Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract)
Arm Title
Control + Product 2
Arm Type
Active Comparator
Arm Description
Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract)
Arm Title
Control + Product 3
Arm Type
Active Comparator
Arm Description
Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract)
Intervention Type
Other
Intervention Name(s)
cinnamon extract
Intervention Description
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Intervention Type
Other
Intervention Name(s)
lemon extract
Intervention Description
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Intervention Type
Other
Intervention Name(s)
lemon extract plus eucalyptus extract
Intervention Description
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Intervention Type
Other
Intervention Name(s)
Thicken Up clear: TUC
Primary Outcome Measure Information:
Title
Improvement of the safety of the swallowing function, according to Rosenbek's scale
Description
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.
Time Frame
up to15 min after ingredient ingestion
Secondary Outcome Measure Information:
Title
Swallowing safety-Prevalence of penetration
Description
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.
Time Frame
up to15 min after ingredient ingestion
Title
Swallowing safety-Prevalence of aspiration
Description
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.
Time Frame
up to15 min after ingredient ingestion
Title
Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues
Description
Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time Frame
up to15 min after ingredient ingestion
Title
Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues
Description
Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time Frame
up to15 min after ingredient ingestion
Title
Efficacy of swallowing function-Time to upper oesophageal sphincter opening
Description
Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time Frame
up to15 min after ingredient ingestion
Title
Efficacy of swallowing function-Time to laryngeal vestibule opening
Description
Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time Frame
up to15 min after ingredient ingestion
Title
Efficacy of swallowing function-time to laryngeal vestibule closure
Description
time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Time Frame
up to15 min after ingredient ingestion
Title
Modification of brain physiology response to sensory input:
Description
Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG.
Time Frame
up to 20 min after ingredient ingestion
Title
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).
Description
using questionnaire
Time Frame
ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested
Title
palatability using a questionnaire, assessed during EEG sessions (V3 and V4)
Description
using questionnaire
Time Frame
ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Clavé, Md/PhD
Organizational Affiliation
Hospital de Mataro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

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

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