UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020661 |
|---|---|
| Receipt number | 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 15:04:43 |
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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
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
songeejung@hotmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023848
