UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029528 |
|---|---|
| Receipt number | R000033741 |
| Scientific Title | The effect of intaking medium- chain triglycerides in dysphagia patients |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2019/10/21 08:16:40 |
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Basic information
Public title
The effect of intaking medium- chain triglycerides in dysphagia patients
Acronym
Intaking medium- chain triglycerides on dysphagia patients
Scientific Title
The effect of intaking medium- chain triglycerides in dysphagia patients
Scientific Title:Acronym
Intaking medium- chain triglycerides on dysphagia patients
Region
| Japan |
Condition
Condition
elderly with dysphagia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a report that medium-chain triglycerides (MCT) has an effect on increasing muscle mass in elderly. However, the fact that MCT has an effect on enhancing swallowing function in dysphagic elderly remain unclear. In present study, we'll study the effect of intaking MCT in dysphagic elderly in randomized control study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
meal time, nutrition status and swallowing function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intaking of Medium- chain fatty acid
Interventions/Control_2
Intaking of Long- chain fatty acid
Interventions/Control_3
No intervention
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly with dysphagia
Key exclusion criteria
Subject having sever heart failure or lung, or liver or kidney disease.
Subject having larger than 23 of BMI.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences,
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
0358035562
haruka-t@rd5.so-net.ne.j
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
0358035562
Homepage URL
koji19831031@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo
Tel
03-5803-5562
info.bec@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
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
