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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020661
Receipt No. R000023848
Scientific Title Effects of milk fat globule membrane on muscle function recovery after bed rest: an exploratory trail
Date of disclosure of the study information 2016/02/01
Last modified on 2019/03/20

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Basic information
Public title Effects of milk fat globule membrane on muscle function recovery after bed rest: an exploratory trail
Acronym Observation of muscle function recovery process after bed rest with milk fat globule membrane (MFGM)
Scientific Title Effects of milk fat globule membrane on muscle function recovery after bed rest: an exploratory trail
Scientific Title:Acronym Observation of muscle function recovery process after bed rest with milk fat globule membrane (MFGM)
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the effects of exercise and milk fat globule membrane intake after bed rest on recovery process of skeletal muscle function and muscle mass
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change in muscle function on 2 and 4th weeks after bed rest
Key secondary outcomes Change in muscle mass, muscle phenotype, physical performance, and blood biochemistry

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Exercise and milk fat globule membrane (MFGM) intake after bed rest
6 tablets per day, once a day, 4 weeks after bed rest
Interventions/Control_2 Exercise and placebo (milk components intake without milk fat globule membrane (MFGM)) after bed rest
6 tablets per day, once a day, 4 weeks after bed rest
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
20 years-old <=
Age-upper limit
25 years-old >=
Gender Male
Key inclusion criteria 1) non-smoking, 2) not dependent on
alcohol and drug, 3) healthy mental
and physical, 4) 160-190 cm of height, 5) no less than 23 kg/m2 of BMI, 6) did not participate in other clinical trials
within 1 year, 7) agree with informed consent, 8) did not intake other supplements within 1 month, 9)have motivation and significance to participate in trial

Key exclusion criteria have presence of: 1) chronic illness or
medication, 2) chronic backache disease, 3) urolithiasis, 4) orthostatic
hypotension, 5) circulatory disease, 6) nervous system disease, 7) abnormality in an electrocardiogram, 8) artificial joints
or other type of metal objects in body, 9) family history of thrombus, 10) food allergy, 11) in the caused ill feelings by blood collection, 12) medical history (cerebrovascular disease, heart disease), 13) positive for hepatitis B or C test, 14) are prohibited to participate in trail by safety manager
Target sample size 4

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Yamazaki
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3219
Email masashiy@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Songee
Middle name
Last name Jung
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5600(8365)
Homepage URL
Email songeejung@hotmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan Aerospace Exploration Agency (JAXA)
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
Tel 029-853-3219
Email masashiy@md.tsukuba.ac.jp

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 筑波大学付属病院(茨城県)
University of Tsukuba Hospital(Ibaraki)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 4
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
2015 Year 11 Month 18 Day
Date of IRB
2016 Year 02 Month 05 Day
Anticipated trial start date
2016 Year 02 Month 06 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023848

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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