UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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.

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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

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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	Osamu Ezaki, Sachiko Abe
Organization	Showa Women's University
Division name	Department of Human Life Science and Culture, Graduate School of Human Life Sciences
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	Osamu Ezaki
Organization	Showa Women's University
Division name	Department of Human Life Science and Culture, Graduate School of Human Life Sciences
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 23 Day
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

Related information
URL releasing protocol	http://www09.swu.ac.jp/cybozu/db.exe?page=DBView&did=4140
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020355