UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017567
Receipt number R000020355
Scientific Title Studies on effects of addition of medium-chain triglyceride (MCT) or long-chain triglyceride (LCT) to an amino acids- enriched supplement on muscle and cognitive function in elderly subjects.
Date of disclosure of the study information 2015/05/14
Last modified on 2016/05/14 11:36:35

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Basic information

Public title

Studies on effects of addition of medium-chain triglyceride (MCT) or long-chain triglyceride (LCT) to an amino acids- enriched supplement on muscle and cognitive function in elderly subjects.

Acronym

Effects of combination of medium-chain triglyceride and leucine-enriched supplement on muscle and mental function.

Scientific Title

Studies on effects of addition of medium-chain triglyceride (MCT) or long-chain triglyceride (LCT) to an amino acids- enriched supplement on muscle and cognitive function in elderly subjects.

Scientific Title:Acronym

Effects of combination of medium-chain triglyceride and leucine-enriched supplement on muscle and mental function.

Region

Japan


Condition

Condition

Frail elderly subjects

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of addition of medium-chain triglyceride (MCT) to a leucine- and vitamin D-rich supplement, compared to long-chain fatty acids (LCT), in frail elderly subjects.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Muscle function (locomotive and respiratory) and cognitive function at baseline and after 3-mo intervention are compared.
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 and iteration numbers in legs open and close; strength of respiratory muscles is estimated by peak expiratory flow (PEF) ;cognitive function is estimated by Mini-Mental State Examination (MMSE) and NM scale.

Key secondary outcomes

Under fasting conditions, blood concentrations in total protein, albumin, creatinine, total cholesterol, HDL-cholesterol, LDL-cholesterol, Triacylglycerol, free fatty acid, choline esterase, blood sugar, HbA1c, white blood cell number, red blood cell number, hemoglobin concentration, hematocrit, platelet number, iron concentration, C-reactive protein, acetoacetic acid, 3-hydroxybutyric acid, and total ketone bodies at baseline and after 3-mo intervention are compared.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The first group receives leucine-, vitamin D-enrich supplement plus MCT (leucine + 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 kindly provided by the 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 leucine-, vitamin D-enrich supplement plus LCT(leucine + LCT), as a control to a MCT addition.
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.
LCT containing C18:1 64%, C18:2 19% is kindly provided by the 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_3

The third group does not receive any supplements (control), as a control to supplemented groups.

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

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Ezaki, Sachiko Abe

Organization

Showa Women's University

Division name

Department of Human Life Science and Culture, Graduate School of Human Life Sciences

Zip code


Address

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

TEL

03-3411-7450

Email

ezaki@swu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Ezaki

Organization

Showa Women's University

Division name

Department of Human Life Science and Culture, Graduate School of Human Life Sciences

Zip code


Address

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

TEL

03-3411-7450

Homepage URL


Email

ezaki@swu.ac.jp


Sponsor or person

Institute

Showa Women's University

Institute

Department

Personal name



Funding Source

Organization

None

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


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

介護老人保健施設スカイ(Day Care SKY)(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 14 Day


Related information

URL releasing protocol

http://www09.swu.ac.jp/cybozu/db.exe?page=DBView&did=4140

Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 07 Month 23 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 17 Day

Last follow-up date

2014 Year 12 Month 15 Day

Date of closure to data entry

2015 Year 05 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Abe S, Ezaki O, Suzuki M. Medium-Chain Triglycerides in Combination with Leucine and Vitamin D Increase Muscle Strength and Function in Frail Elderly Adults in a Randomized Controlled Trial. J Nutr. 2016 May;146(5):1017-26. doi: 10.3945/jn.115.228965. Epub 2016 Apr 13. PubMed PMID: 27075909.


Management information

Registered date

2015 Year 05 Month 14 Day

Last modified on

2016 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name