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临床试验/NCT04305860
NCT04305860已完成不适用

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

Complexo Hospitalario Universitario de A Coruña1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Taste

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Modified starch without flavoring (Dietary Supplement)

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.

干预措施: Mofidied starch with Bi1 aromas (Dietary Supplement)

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.

干预措施: Xanthan gum without flavoring (Dietary Supplement)

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.

干预措施: Xanthan gum with Bi1 aromas (Dietary Supplement)

结局指标

主要结局

Taste

时间窗: 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).

Hydratation

时间窗: 3 days during hospitalization

Volume of water ingested (ml)

Overall valoration

时间窗: 3 days during hospitalization

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

Appearance

时间窗: 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).

Odor

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Complexo Hospitalario Universitario de A Coruña
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfonso Vidal Casariego

Principal Investigator

Complexo Hospitalario Universitario de A Coruña

研究点 (1)

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