UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024735
Receipt number 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 11:48:31

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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 or person

Institute

University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.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