UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000023302
Receipt number	R000026751
Scientific Title	Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.
Date of disclosure of the study information	2016/08/01
Last modified on	2019/07/27 15:09:28

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Basic information

Public title

Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.

Acronym

Effects of medium-chain triglyceride on muscle and cognitive function.

Scientific Title

Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.

Scientific Title:Acronym

Effects of medium-chain triglyceride on muscle and cognitive function.

Region

Japan

Condition

Frail elderly subjects

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To examine whether medium-chain triglycerides (MCT) per se could increase muscle and cognitive function in frail elderly subjects.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Iteration numbers in legs open and close

Key secondary outcomes

Muscle function (locomotive and respiratory) and cognitive function at baseline, during 3-mo intervention and at washout are measured.
Mid-upper-arm muscle area (AMA) is estimated by measuring triceps skin fold thickness (TSF) and mid-upper-arm circumference (AC); strength in the upper extremities is measured by a handgrip dynamometry; strength in the lower extremities is estimated by the leg extension power.
Muscle function is estimated by gait speed; swallowing ability is estimated by repetitive saliva swallowing test; strength of respiratory muscles is estimated by peak expiratory flow (PEF); ADL is estimated by Functional Independence Measure (FIM).
Cognitive function is estimated by Mini-Mental State Examination (MMSE), NM scale, and Neuropsychiatric Inventory Nursing Home Version (NPI-NH).

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Numbered container method

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The first group (positive control) receives leucine-, vitamin D-enrich supplement plus MCT (LD + MCT) at dinner.
The leucine-, vitamin D-enrich supplement (Amino L40) produced by Ajinomoto Inc. (Tokyo, Japan) is purchased. One tube (100 g, 30 kcal) of Amino L40 is given at the beginning of dinner. One tube contains EAA 3 g (leucine 1.2 g, isoleucine 0.3 g, valine 0.3 g, other amino acids 1.2 g), vitamin D 20 ug (800 IU), vitamin B1 0.2 mg, vitamin B6 0.2 mg, vitamin B12 0.4 ug and water 87g.
MCT containing C8:0 75%, C10:0 25% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of MCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.

Interventions/Control_2

The second group receives MCT only.
MCT containing C8:0 75%, C10:0 25% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of MCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.

Interventions/Control_3

The third group (negative control) receives LCT only.
LCT containing C18:1 64%, C18:2 19% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of LCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.

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

Elderly subjects in a nursing care home for the elderly volunteered to participate in a 3-mo dietary supplement intervention program.
All residents in this nursing care home need special care by other people for living. They are classified into Japanese nursing care levels with number between 1 and 5 based on assessed care needs.

Key exclusion criteria

Exclusion criteria are subjects with treated with parenteral nutrition, or difficulty of swallowing, or type 1 diabetes mellitus, severe heart failure, liver, kidney, blood disease, or FBS > 200 mg/dl, or blood creatinine > 1.5 mg/dl or CRP > 2.0 mg/dl or BMI > 23 to avoid a further increase in body weight, or food allergy to supplements used in this study.

Target sample size

Research contact person

Name of lead principal investigator

1st name osamu

Middle name

Last name ezaki

Organization

Showa Women's University

Division name

Institute of Women's Health Science

Zip code

154-8533

Address

1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN

TEL

03-3411-7450

Email

ezaki1952@yahoo.co.jp

Public contact

Name of contact person

1st name osamu

Middle name

Last name ezaki

Organization

Showa Women's University

Division name

Institute of Women's Health Science

Zip code

154-8533

Address

1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN

TEL

03-3411-7450

Homepage URL

Email

ezaki1952@yahoo.co.jp

Sponsor or person

Institute

Showa Women's University

Institute

Department

Personal name

Funding Source

Organization

Showa Women's University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Human Ethics Committee of Showa Women's University

Address

1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN

Tel

03-3411-7351

Email

rinri-iin@swu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

介護老人保健施設スカイ(Day Care SKY)

Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 01 Day

Related information

URL releasing protocol

https://doi.org/10.1093/ajcn/nqz138

Publication of results

Published

Result

URL related to results and publications

https://doi.org/10.1093/ajcn/nqz138

Number of participants that the trial has enrolled

Results

Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544

Results date posted

2019 Year 07 Month 27 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2019 Year 07 Month 23 Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 07 Month 01 Day

Date of IRB

2016 Year 07 Month 01 Day

Anticipated trial start date

2016 Year 08 Month 25 Day

Last follow-up date

2017 Year 02 Month 28 Day

Date of closure to data entry

2017 Year 05 Month 30 Day

Date trial data considered complete

2017 Year 08 Month 31 Day

Date analysis concluded

2018 Year 08 Month 31 Day

Other

Other related information

Management information

Registered date

2016 Year 07 Month 23 Day

Last modified on

2019 Year 07 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026751

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name