Acceptance of Different Thickeners in Dysphagia

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

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

Study Overview

• Status: Completed
• Conditions: Dysphagia; Dysphagia, Oropharyngeal
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • La Coruna
    • A Coruña, La Coruna, Spain, 15006
      • Alfonso Vidal-Casariego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Complexo Hospitalario Universitario de A Coruña

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Dysphagia; Thickener; Flavoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2019-527

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No