UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041674 |
|---|---|
| Receipt number | R000047562 |
| Scientific Title | Effect and safety of thickened carbonated beverages in patient with dysphagia |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2023/03/16 14:57:32 |
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Basic information
Public title
Effect and safety of thickened carbonated beverages in patient with dysphagia
Acronym
Effect and safety of thickened carbonated beverages in patient with dysphagia
Scientific Title
Effect and safety of thickened carbonated beverages in patient with dysphagia
Scientific Title:Acronym
Effect and safety of thickened carbonated beverages in patient with dysphagia
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to verify the effectiveness and safety of thickened carbonated beverages in patients with dysphagia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Videoendoscopic examination of swallowing(VE) is performed to evaluate swallowing function when ingesting thickened carbonated beverage and normal thickened water.
We investigate whether the carbonic acid affects the aspiration, pharyngeal residues, and swallowing reflex.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1.drink 5cc thickened carbonated beverage 3 times.
2.drink 5cc normal thickened water 3 times.
Interventions/Control_2
1.drink 5cc normal thickened water 3 times.
2.drink 5cc thickened carbonated beverage 3 times.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient with dysphagia
patient with dysphagia suspected
Key exclusion criteria
unstable physical or mental status
unable to perform VE due to severe dysphagia
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kazuharu |
| Middle name | |
| Last name | Nakagawa |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Depertment of Dysphagia rehabiritation
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
TEL
0358034560
nakagerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Yoshimi |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Depertment of Dysphagia rehabiritation
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
TEL
0358035562
Homepage URL
k.yoshimi.gerd@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
Tel
0358035562
k.yoshimi.gerd@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-022-25926-4
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-022-25926-4
Number of participants that the trial has enrolled
38
Results
The reduction in the amount of residue in both the vallecula (p = 0.007) and pyriform sinus (p = 0.004) was greater after ingestion of thickened carbonated cola than thickened non-carbonated cola. The onset of the swallowing reflex was significantly earlier after ingestion of thickened carbonated cola than thickened non-carbonated cola (p = 0.007). There were no significant differences in the extent of penetration.
Results date posted
| 2023 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were diagnosed with dysphagia based on swallowing function assessment, including videoendoscopic examinations or video fluoroscopic examinations prior to the study's implementation.
Participant flow
The exclusion criteria were those who had difficulties during swallowing evaluation with severe aspiration, significant medical disorders, functional oral intake scale (FOIS)6 score of 7, and non-consent to enrollment.
Adverse events
None
Outcome measures
Aspiration, penetration, pharyngeal residue, and initiation position of the swallowing reflex were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047562
