Acceptance of Different Thickeners in Dysphagia

NCT04305860 | Completed

• 1 other identifier: 2019-527
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphagia; Dysphagia, Oropharyngeal

Keywords

Thickener; Flavoring; Dysphagia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Modified starch without flavoring

ACTIVE COMPARATOR

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

Modified starch with flavoring

ACTIVE COMPARATOR

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

Xanthan gum without flavoring

ACTIVE COMPARATOR

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

Xanthan gum with flavoring

ACTIVE COMPARATOR

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

Modified starch without flavoring DIETARY_SUPPLEMENT

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

Modified starch without flavoring

Mofidied starch with Bi1 aromas DIETARY_SUPPLEMENT

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

Modified starch with flavoring

Xanthan gum without flavoring DIETARY_SUPPLEMENT

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

Xanthan gum without flavoring

Xanthan gum with Bi1 aromas DIETARY_SUPPLEMENT

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

Xanthan gum with flavoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña: lead

Study Sites (1)

Alfonso Vidal-Casariego

A Coruña, La Coruna, 15006, Spain

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Flavoring Agents; xanthan gum

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot study of nutritional intervention, randomized, and controlled

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 12, 2020
• Study Start: February 3, 2020
• Primary Completion: February 28, 2020
• Study Completion: March 3, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

ES (1)