Skip to content

Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice

Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163355
Enrollment
50
Registered
2017-05-23
Start date
2017-05-01
Completion date
2018-09-04
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing Disorder

Keywords

pureed diet, dysphasia

Brief summary

The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.

Detailed description

The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia. The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows: 1. No remains 2. Pharyngeal clearance is obtained after swallowing of test jelly once 3. Pharyngeal clearance is obtained after swallowing of test jelly twice 4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more 5. In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx. Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Interventions

OTHERa gelling agent

Pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan) is compared with the standard purred rice in the condition of swallowing.

Sponsors

Showa Inan General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital

Exclusion criteria

* an age less than 65 years old or the presence of an acute infection.

Design outcomes

Primary

MeasureTime frameDescription
The pharyngeal clearance score (1-5)24 months1. No remains 2. Pharyngeal clearance is obtained after swallowing of test jelly once 3. Pharyngeal clearance is obtained after swallowing of test jelly twice 4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more 5. In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx.

Secondary

MeasureTime frameDescription
Patient feeling regarding pharyngeal clearance24 monthsPatient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026