UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035365
Receipt number R000040301
Scientific Title Effects of Medium-Chain Triglyceride on ghrelin activation, food intake, activity of daily living and muscle mass in older malnourished patients with stroke.
Date of disclosure of the study information 2018/12/28
Last modified on 2019/03/01 00:59:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of Medium-Chain Triglyceride on ghrelin activation, food intake, activity of daily living and muscle mass in older malnourished patients with stroke.

Acronym

Medium-chain triglyceride and ghrelin in stroke

Scientific Title

Effects of Medium-Chain Triglyceride on ghrelin activation, food intake, activity of daily living and muscle mass in older malnourished patients with stroke.

Scientific Title:Acronym

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

1st name
Middle name
Last name Sayuri Shimazu

Organization

Kumamoto Rehabilitation Hospital

Division name

Nutrition Management

Zip code


Address

760 Magate, Kikuyo-machi, Kikuchi, Kumamoto, Japan

TEL

0962323111

Email

shimazu@krh.marutakai.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Yoshimura

Organization

Kumamoto Rehabilitation Hospital

Division name

Rehabilitation Medicine

Zip code


Address

760 Magate, Kikuyo-machi, Kikuchi, Kumamoto, Japan

TEL

0962323111

Homepage URL


Email

hanley.belfus@gmail.com


Sponsor or person

Institute

Kumamoto Rehabilitation Hospital

Institute

Department

Personal name



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)



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

2018 Year 12 Month 28 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

Preinitiation

Date of protocol fixation

2019 Year 03 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040301


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name