Acceptance of Different Thickeners in Dysphagia

NCT ID: NCT04305860

Last Updated: 2020-03-12

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2020-03-03

Brief Summary

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Randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.

Detailed Description

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Background:

In patients with dyaphagia the modification of viscosity of oral liquids with thickeners ia needed to guarantee an effective and safe swallowing, and to ensure a proper state of hydration. There are two types of thickeners: thickeners obtained from modified starch or from food gums (suchxanthan gum)

Aim:

To evaluate the acceptance of different types of thickeners, with and without the addition of flavorings, and their relationship with water intake.

Methods:

Randomized, controlled, pilot study of nutritional intervention. Forty hospitalized patients with oropharyngeal dysphagia were randomized to 4 parallel groups: modified starch without flavoring, modified starch with flavoring, xanthan gum without flavoring, xanthan gum with flavoring. Each patient was asked to assess the odor, taste, appearance, and overall valoration of the thickened liquid with the different preparations, using a structured questionnaire. The number of glasses consumed by the patient over 3 consecutive days was also recorded to calculate de volume of liquid they consumed.

Conditions

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Dysphagia Dysphagia, Oropharyngeal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study of nutritional intervention, randomized, and controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified starch without flavoring

Patients thicken water with modified starch during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.

Group Type ACTIVE_COMPARATOR

Modified starch without flavoring

Intervention Type DIETARY_SUPPLEMENT

Each patient of this group receives the thickener during three days of hospitalization

Modified starch with flavoring

Patients thicken water with modified starch adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.

Group Type ACTIVE_COMPARATOR

Mofidied starch with Bi1 aromas

Intervention Type DIETARY_SUPPLEMENT

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Xanthan gum without flavoring

Patients thicken water with xanthan gum during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.

Group Type ACTIVE_COMPARATOR

Xanthan gum without flavoring

Intervention Type DIETARY_SUPPLEMENT

Each patient of this group receives the thickener during three days of hospitalization

Xanthan gum with flavoring

Patients thicken water with xanthan gum adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization.They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.

Group Type ACTIVE_COMPARATOR

Xanthan gum with Bi1 aromas

Intervention Type DIETARY_SUPPLEMENT

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Interventions

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Modified starch without flavoring

Each patient of this group receives the thickener during three days of hospitalization

Intervention Type DIETARY_SUPPLEMENT

Mofidied starch with Bi1 aromas

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Intervention Type DIETARY_SUPPLEMENT

Xanthan gum without flavoring

Each patient of this group receives the thickener during three days of hospitalization

Intervention Type DIETARY_SUPPLEMENT

Xanthan gum with Bi1 aromas

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener.

Exclusion Criteria

* Patients with expected hospital length of stay less than 24 hours.
* Patients with food allergy to any of the ingredients of the thickener or flavorings used in the study.
* Patients with cognitive impairment that prevents collaborating in obtaining data.
* Patients in terminal situations, in which death is expected in the following hours.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complexo Hospitalario Universitario de A Coruña

OTHER

Sponsor Role lead

Responsible Party

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Alfonso Vidal Casariego

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alfonso Vidal-Casariego

A Coruña, La Coruna, Spain

Site Status

Countries

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Spain

Other Identifiers

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2019-527

Identifier Type: -

Identifier Source: org_study_id

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