Acceptance of Different Thickeners in Dysphagia

Dysphagia Clinical Trial

Official title:

Acceptance of Different Types of Thickeners, With and Without Flavoring, in Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305860
• Other study ID #: 2019-527
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2020
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 3, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Dysphagia, Oropharyngeal

Intervention

Dietary Supplement:
• Modified starch without flavoring
Each patient of this group receives the thickener during three days of hospitalization
• Mofidied starch with Bi1 aromas
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
• Xanthan gum without flavoring
Each patient of this group receives the thickener during three days of hospitalization
• Xanthan gum with Bi1 aromas
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Locations

Country	Name	City	State
Spain	Alfonso Vidal-Casariego	A Coruña	La Coruna

Sponsors (1)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydratation	Volume of water ingested (ml)	3 days during hospitalization
Primary	Taste	Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).	3 days during hospitalization
Primary	Odor	Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).	3 days during hospitalization
Primary	Appearance	Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).	3 days during hospitalization
Primary	Overall valoration	Quantiative scale of Punctuation: 0-10 points (very bad to very good).	3 days during hospitalization