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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017567
Receipt No. 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

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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
Institute Showa Women's University
Institute
Department

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
URL(English) https://upload.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


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