UMIN-CTR Clinical Trial

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
Email	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
Email	koji19831031@gmail.com

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033741