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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024735
Receipt No. R000028153
Scientific Title Change in muscle mass and strength after weight loss through dietary restriction in obese men
Date of disclosure of the study information 2016/11/08
Last modified on 2016/11/07

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Basic information
Public title Change in muscle mass and strength after weight loss through dietary restriction in obese men
Acronym Muscle strength after diet-induced weight reduction
Scientific Title Change in muscle mass and strength after weight loss through dietary restriction in obese men
Scientific Title:Acronym Muscle strength after diet-induced weight reduction
Region
Japan

Condition
Condition Obesity
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the evidence for the influence of muscle mass reduction caused by diet-induced considerable weight reduction on muscle strength in obese men.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle mass and strength
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 24 obese men attended a 12-week weight reduction program that implemented dietary restrictions.
Interventions/Control_2
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
30 years-old <=
Age-upper limit
64 years-old >=
Gender Male
Key inclusion criteria 1) body mass index over 25 kg/m2,
2) males between 30 and 64 years of age,
3) no intentional decrease in body weight greater than 5% in the past 12 months
4) no terminal disease, recent muscle injury, or surgery.
Key exclusion criteria 1) Subjects without serious major heart problems
2) Subjects who can not take written informed consent
3) Subjects determined to be inappropriate by physician
4) Subjects who did not receive allocated intervention
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka_Kiyoji
Organization University of Tsukuba
Division name Faculty of Health and Sports Science
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL 029-853-8365
Email tanaka@taiiku.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bokun Kim
Organization University of Tsukuba
Division name Sports Medicine, Graduate School of Comprehensive Human Science
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL 029-853-8365
Homepage URL
Email sechang.oh.maxi@gmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 08 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
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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 07 Day
Last modified on
2016 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028153

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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