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

NCT ID: NCT02422576

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control + Product 1

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

Group Type ACTIVE_COMPARATOR

cinnamon extract

Intervention Type OTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Thicken Up clear: TUC

Intervention Type OTHER

Control + Product 2

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

Group Type ACTIVE_COMPARATOR

lemon extract

Intervention Type OTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Thicken Up clear: TUC

Intervention Type OTHER

Control + Product 3

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

Group Type ACTIVE_COMPARATOR

lemon extract plus eucalyptus extract

Intervention Type OTHER

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Thicken Up clear: TUC

Intervention Type OTHER

Interventions

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cinnamon extract

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Intervention Type OTHER

lemon extract

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Intervention Type OTHER

lemon extract plus eucalyptus extract

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Intervention Type OTHER

Thicken Up clear: TUC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pere Clavé, Md/PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataro

Locations

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Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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14.13.NRC

Identifier Type: -

Identifier Source: org_study_id