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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name