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CompletedNCT04305860Updated Mar 12, 2020

Acceptance of Different Thickeners in Dysphagia

An interventional study of Modified starch without flavoring and Mofidied starch with Bi1 aromas in Dysphagia and Dysphagia, Oropharyngeal, sponsored by Complexo Hospitalario Universitario de A Coruña. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Complexo Hospitalario Universitario de A Coruña · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dysphagia
  • Dysphagia, Oropharyngeal

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Keywords

  • Thickener
  • Flavoring
  • Dysphagia
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Complexo Hospitalario Universitario de A Coruña is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementModified starch without flavoring

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

  • Dietary supplementMofidied starch with Bi1 aromas

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

  • Dietary supplementXanthan gum without flavoring

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

  • Dietary supplementXanthan gum with Bi1 aromas

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

06

What researchers measure

Primary outcomes

  1. Hydratation

    Volume of water ingested (ml)

    Time frame: 3 days during hospitalization

  2. Taste

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

    Time frame: 3 days during hospitalization

  3. Odor

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

    Time frame: 3 days during hospitalization

  4. Appearance

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

    Time frame: 3 days during hospitalization

  5. Overall valoration

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

    Time frame: 3 days during hospitalization

07

Study locations

1 site
  • Alfonso Vidal-Casariego
    A Coruña, La Coruna 15006, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04305860
Lead sponsor
Complexo Hospitalario Universitario de A Coruña
Responsible party
Alfonso Vidal Casariego (Principal Investigator, Complexo Hospitalario Universitario de A Coruña) — Principal investigator
First posted
Mar 12, 2020
Start date
Feb 3, 2020
Primary completion
Feb 28, 2020
Completion
Mar 3, 2020
Last update
Mar 12, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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