UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009249
Receipt number R000010860
Scientific Title The effects of viscosities on mastication and swallowing in frail elderlies
Date of disclosure of the study information 2012/11/03
Last modified on 2015/07/08 08:55:50

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Basic information

Public title

The effects of viscosities on mastication and swallowing in frail elderlies

Acronym

The effects of viscosities on mastication and swallowing in frail elderlies

Scientific Title

The effects of viscosities on mastication and swallowing in frail elderlies

Scientific Title:Acronym

The effects of viscosities on mastication and swallowing in frail elderlies

Region

Japan


Condition

Condition

people with dysphagia

Classification by specialty

Medicine in general Rehabilitation medicine Dental medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

When eating two-phase food including solid and liquid, the liquid component enters the hypopharynx frequently (Saitoh et al., 2007). When the liquid is in the hypopharynx, the larynx is open, which increases a risk of aspiration.
In our priliminary study, we revealed that increased viscosity in two-phase food significantly delayed food transport to the pharynx (Matsuo et al., 2012).
The purpose of this study was to examine the effects of increased viscosities in two-phase food on mastication, food transport and swallowing.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

bolus location at swallow onset, masticatory time, presense of aspiration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Food

Interventions/Control_1

presense of dysphagia

Interventions/Control_2

no dysphagia

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

normal old people and frail elderly in nursing homes

Key exclusion criteria

i) hemorrhagic diathesis, ii) low cognition, iii) alergic to the test food, iV) severe dysphagia

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Matsuo

Organization

Fujita Health University, School of Medicine

Division name

Department of Dentistry

Zip code


Address

1-98 Dengakugakubo Kutsukake-cho Toyoake

TEL

0562-93-2000

Email

kmatsuo@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Matsuo

Organization

Fujita Health Unversity

Division name

Department of Dentistry

Zip code


Address

1-98 Dengakugakubo Kutsukake-cho Toyoake

TEL

0562-93-2000

Homepage URL


Email

kmatsuo@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health Unversity

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 11 Month 03 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 05 Day

Last follow-up date

2013 Year 01 Month 01 Day

Date of closure to data entry

2013 Year 01 Month 01 Day

Date trial data considered complete

2014 Year 01 Month 01 Day

Date analysis concluded

2014 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 11 Month 02 Day

Last modified on

2015 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name