Acceptance of Different Thickeners in Dysphagia

Complexo Hospitalario Universitario de A Coruña

Status: Completed

Conditions: Dysphagia; Dysphagia, Oropharyngeal

Treatments: Dietary Supplement: Xanthan gum with Bi1 aromas; Dietary Supplement: Modified starch without flavoring; Dietary Supplement: Xanthan gum without flavoring; Dietary Supplement: Mofidied starch with Bi1 aromas

Study type: Interventional

Funder types: Other

Identifiers

NCT04305860

2019-527

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

Modified starch without flavoring

Active Comparator group

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.

Treatment:

Dietary Supplement: Modified starch without flavoring

Modified starch with flavoring

Active Comparator group

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.

Treatment:

Dietary Supplement: Mofidied starch with Bi1 aromas

Xanthan gum without flavoring

Active Comparator group

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.

Treatment:

Dietary Supplement: Xanthan gum without flavoring

Xanthan gum with flavoring

Active Comparator group

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.

Treatment:

Dietary Supplement: Xanthan gum with Bi1 aromas