UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Medium-Chain Triglyceride on ghrelin activation, food intake, activity of daily living and muscle mass in older malnourished patients with stroke.
Title of the study (Brief title)	Medium-chain triglyceride and ghrelin in stroke
Region	Japan

Condition
Condition	Malnutrition / stroke
Classification by specialty	Neurology Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of medium-chain triglyceride on ghrelin activation, food intake, activity of daily living, and muscle mass in older malnourished patients with stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Functional Independence Measure
Key secondary outcomes	serum level of acylated ghrelin serum level of IGF-1 food intake; energy and protein skeletal muscle mass index handgrip strength

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	MCT plus Protein
Interventions/Control_2	LCT plus Protein
Interventions/Control_3	Protein
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Older patients aged 70 or older undergoing convalescent rehabilitation 2. Malnourished: MNA-SF<7 and BMI<20.0kg/m2 3. Can perform sit-up and down exercise w/o any aids
Key exclusion criteria	1. Unconscious: JCS>II-10 2. Severe cognitive decline: MMSE<20 3. Dysphagia: FILS<3 4. Judged medically inappropriate condition for participation in research
Target sample size	45

Research contact person
Name of lead principal investigator	Sayuri Shimazu
Organization	Kumamoto Rehabilitation Hospital
Division name	Nutrition Management
Address	760 Magate, Kikuyo-machi, Kikuchi, Kumamoto, Japan
TEL	0962323111
Email	shimazu@krh.marutakai.or.jp

Public contact
Name of contact person	Yoshihiro Yoshimura
Organization	Kumamoto Rehabilitation Hospital
Division name	Rehabilitation Medicine
Address	760 Magate, Kikuyo-machi, Kikuchi, Kumamoto, Japan
TEL	0962323111
Homepage URL
Email	hanley.belfus@gmail.com

Sponsor
Institute	Kumamoto Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Nissin Oilio group
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 12 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 03 Month 01 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 26 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040301