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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024005 |
Receipt No. | R000027637 |
Scientific Title | Dietary milk fat globule membrane with semiweekly light exercise improves choice stepping reaction time in healthy Japanese elderly subjects: A randomized double blind, placebo-controlled trial. |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/09/13 |
Basic information | ||
Public title | Dietary milk fat globule membrane with semiweekly light exercise improves choice stepping reaction time in healthy Japanese elderly subjects: A randomized double blind, placebo-controlled trial. | |
Acronym | Combination effect of milk fat globule membrane and light exercise on agility in healthy Japanese elderly. | |
Scientific Title | Dietary milk fat globule membrane with semiweekly light exercise improves choice stepping reaction time in healthy Japanese elderly subjects: A randomized double blind, placebo-controlled trial. | |
Scientific Title:Acronym | Combination effect of milk fat globule membrane and light exercise on agility in healthy Japanese elderly. | |
Region |
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Condition | |||
Condition | Healthy elderly | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To elucidate the combination effect of milk fat globule membrane intake and light exercise on agility in healthy elderly. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Choice stepping reaction time before and after the 5-week intervention (daily intake of test tablets and semiweekly light exercise) |
Key secondary outcomes | Muscle mass before and after the 5-week intervention (daily intake of test tablets and semiweekly light exercise) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Daily intake of milk fat globule membrane containing tablets, and semiweekly light exercise (30 min/day) for 5 weeks. | ||
Interventions/Control_2 | Daily intake of placebo tablets, and semiweekly light exercise (30 min/day) for 5 weeks. | ||
Interventions/Control_3 | |||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | -A person who hasn't had a motor dysfunction.
-A person who is able to participate in a functional fitness test. -A person who hasn't used a cardiac pacemaker and/or an artificial joint. |
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Key exclusion criteria | -A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system.
-A person who has had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year. -A person who has had dietary allergy. -A person who has taken a lot of milk products. -A person who has had a habit to do strength training. -A person who has been ordered not to do exercise by a medical doctor. -A person who are not eligible due to medical doctor's judgment. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | R&D -Core Technology- Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | 0285-68-7828 | ||||||
ota.noriyasu@kao.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | R&D -Core Technology- Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | 0285-68-7828 | ||||||
Homepage URL | |||||||
soga.satoko@kao.co.jp |
Sponsor | |
Institute | Kao Corporation |
Institute | |
Department |
Funding Source | |
Organization | Kao Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 北斗会宇都宮東病院(栃木県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.jarcp.com/2905-dietary-milk-fat-globule-membrane-with-semiweekly-light-exercise-improves- |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027637 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |