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Completed

NCT Number: NCT04305860

Acceptance of Different Thickeners in Dysphagia

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

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Dysphagia, Oropharyngeal Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfonso Vidal-Casariego

A Coruña, La Coruna, 15006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified starch without flavoring

Dietary Supplement

Each patient of this group receives the thickener during three days of hospitalization

Mofidied starch with Bi1 aromas

Dietary Supplement

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Xanthan gum without flavoring

Dietary Supplement

Each patient of this group receives the thickener during three days of hospitalization

Xanthan gum with Bi1 aromas

Dietary Supplement

Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization

Primary outcomes

  1. Hydratation

    Time frame: 3 days during hospitalization

    Volume of water ingested (ml)

  2. Taste

    Time frame: 3 days during hospitalization

    Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).

  3. Odor

    Time frame: 3 days during hospitalization

    Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).

  4. Appearance

    Time frame: 3 days during hospitalization

    Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).

  5. Overall valoration

    Time frame: 3 days during hospitalization

    Quantiative scale of Punctuation: 0-10 points (very bad to very good).

Sponsors and collaborators

Lead sponsor

Complexo Hospitalario Universitario de A Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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