Acceptance of Different Thickeners in Dysphagia

Study Overview
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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.

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

Conditions
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Dysphagia, Dysphagia, Oropharyngeal

Intervention / Treatment
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* Dietary Supplement: Modified starch without flavoring
* Dietary Supplement: Mofidied starch with Bi1 aromas
* Dietary Supplement: Xanthan gum without flavoring
* Dietary Supplement: Xanthan gum with Bi1 aromas


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study of nutritional intervention, randomized, and controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified starch without flavoring<br>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. | Dietary Supplement: Modified starch without flavoring<br>* Each patient of this group receives the thickener during three days of hospitalization<br>|
| Active Comparator: Modified starch with flavoring<br>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. | Dietary Supplement: Mofidied starch with Bi1 aromas<br>* Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization<br>|
| Active Comparator: Xanthan gum without flavoring<br>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. | Dietary Supplement: Xanthan gum without flavoring<br>* Each patient of this group receives the thickener during three days of hospitalization<br>|
| Active Comparator: Xanthan gum with flavoring<br>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. | Dietary Supplement: Xanthan gum with Bi1 aromas<br>* Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydratation | Volume of water ingested (ml) | 3 days during hospitalization | 
| 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 | 
| 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 | 
| 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 | 
| Overall valoration | Quantiative scale of Punctuation: 0-10 points (very bad to very good). | 3 days during hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thickener, Flavoring, Dysphagia