UMIN-CTR Clinical Trial

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
Last 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
1st 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