Unique ID issued by UMIN | UMIN000017567 |
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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 |
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.
Effects of combination of medium-chain triglyceride and leucine-enriched supplement on muscle and mental function.
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.
Effects of combination of medium-chain triglyceride and leucine-enriched supplement on muscle and mental function.
Japan |
Frail elderly subjects
Not applicable |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
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.
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.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
Central registration
3
Treatment
Food |
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.
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.
The third group does not receive any supplements (control), as a control to supplemented groups.
65 | years-old | <= |
Not applicable |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Osamu Ezaki, Sachiko Abe |
Showa Women's University
Department of Human Life Science and Culture, Graduate School of Human Life Sciences
1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN
03-3411-7450
ezaki@swu.ac.jp
1st name | |
Middle name | |
Last name | Osamu Ezaki |
Showa Women's University
Department of Human Life Science and Culture, Graduate School of Human Life Sciences
1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN
03-3411-7450
ezaki@swu.ac.jp
Showa Women's University
None
Self funding
NO
介護老人保健施設スカイ(Day Care SKY)(神奈川県)
2015 | Year | 05 | Month | 14 | Day |
http://www09.swu.ac.jp/cybozu/db.exe?page=DBView&did=4140
Published
Completed
2014 | Year | 07 | Month | 23 | Day |
2014 | Year | 09 | Month | 17 | Day |
2014 | Year | 12 | Month | 15 | Day |
2015 | Year | 05 | Month | 30 | Day |
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.
2015 | Year | 05 | Month | 14 | Day |
2016 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020355
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