UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change in muscle mass and strength after weight loss through dietary restriction in obese men
Title of the study (Brief title)	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	Tanaka_Kiyoji
Organization	University of Tsukuba
Division name	Faculty of Health and Sports Science
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	Bokun Kim
Organization	University of Tsukuba
Division name	Sports Medicine, Graduate School of Comprehensive Human Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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