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Acceptance of Different Thickeners in Dysphagia

Primary Purpose

Dysphagia, Dysphagia, Oropharyngeal

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Modified starch without flavoring
Mofidied starch with Bi1 aromas
Xanthan gum without flavoring
Xanthan gum with Bi1 aromas
Sponsored by
Complexo Hospitalario Universitario de A Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Thickener, Flavoring, Dysphagia

Eligibility Criteria

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

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.

Sites / Locations

  • Alfonso Vidal-Casariego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Modified starch without flavoring

Modified starch with flavoring

Xanthan gum without flavoring

Xanthan gum with flavoring

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Hydratation
Volume of water ingested (ml)
Taste
Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Odor
Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Appearance
Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Overall valoration
Quantiative scale of Punctuation: 0-10 points (very bad to very good).

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 10, 2020
Sponsor
Complexo Hospitalario Universitario de A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT04305860
Brief Title
Acceptance of Different Thickeners in Dysphagia
Official Title
Acceptance of Different Types of Thickeners, With and Without Flavoring, in Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complexo Hospitalario Universitario de A Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Dysphagia, Oropharyngeal
Keywords
Thickener, Flavoring, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study of nutritional intervention, randomized, and controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified starch without flavoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified starch with flavoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Xanthan gum without flavoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Xanthan gum with flavoring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified starch without flavoring
Intervention Description
Each patient of this group receives the thickener during three days of hospitalization
Intervention Type
Dietary Supplement
Intervention Name(s)
Mofidied starch with Bi1 aromas
Intervention Description
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
Intervention Type
Dietary Supplement
Intervention Name(s)
Xanthan gum without flavoring
Intervention Description
Each patient of this group receives the thickener during three days of hospitalization
Intervention Type
Dietary Supplement
Intervention Name(s)
Xanthan gum with Bi1 aromas
Intervention Description
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
Primary Outcome Measure Information:
Title
Hydratation
Description
Volume of water ingested (ml)
Time Frame
3 days during hospitalization
Title
Taste
Description
Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Time Frame
3 days during hospitalization
Title
Odor
Description
Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Time Frame
3 days during hospitalization
Title
Appearance
Description
Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Time Frame
3 days during hospitalization
Title
Overall valoration
Description
Quantiative scale of Punctuation: 0-10 points (very bad to very good).
Time Frame
3 days during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Alfonso Vidal-Casariego
City
A Coruña
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

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Acceptance of Different Thickeners in Dysphagia

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