UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035075
Receipt number R000039989
Scientific Title Total energy expenditure and body composition in athletes
Date of disclosure of the study information 2018/11/30
Last modified on 2022/03/22 20:06:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Total energy expenditure and body composition in athletes

Acronym

Total energy expenditure and body composition in athletes

Scientific Title

Total energy expenditure and body composition in athletes

Scientific Title:Acronym

Total energy expenditure and body composition in athletes

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate a total energy expenditure and body composition in athletes

Basic objectives2

Others

Basic objectives -Others

This study also evaluate to validity of doubly labeled water and body composition evaluation method

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

Total energy expenditure, fat mass, Fat free mass, %fat

Key secondary outcomes

Accuracy and precession of body composition measurement, Multi-component model, Water turn over


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

The individuals who regularly exercise more than 4 days in a week as athletes
The individuals who unregularly exercise less than 2 days in a week as non-athletes

Key exclusion criteria

Metabolic disorders
Rehabilitant

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Sagayama

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 3058574 Japan

TEL

029-853-3963

Email

sagayama.h@gmail.com


Public contact

Name of contact person

1st name Sagayama
Middle name
Last name Hiroyuki

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 3058574 Japan

TEL

029-853-3963

Homepage URL


Email

sagayama.h@gmail.com


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Japan Society For The Promotion Of Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

Faculty of Health and Sport Sciences

Tel

03-5963-0231

Email

sagayama.h@gmail.com


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

福岡大学
国立スポーツ科学センター
筑波大学


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/sms.14017

Number of participants that the trial has enrolled

31

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 07 Month 06 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 03 Month 01 Day

Date of IRB

2014 Year 01 Month 06 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 11 Month 30 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name