UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011735
Receipt number R000013504
Scientific Title The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle
Date of disclosure of the study information 2013/09/17
Last modified on 2018/11/20 10:16:24

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Basic information

Public title

The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle

Acronym

The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle

Scientific Title

The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle

Scientific Title:Acronym

The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether acute exercise augments diet-induced thermogenesis(DIT), and whether irisin plays a role in the mechanism of post-exercise increment of DIT

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

diet-induced thermogenesis
serum irisin level

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

exercise

Interventions/Control_2

no exercise

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

25 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy, sedentary volunteers who are provided informed, written concent for participation

Key exclusion criteria

Volunteers who have ischemic heart disease, chronic heart failure, hypertension(blood pressure is 140/90mmHg or more), diabetes, or obesity(with body mass index of 30kg/m2 or more)

Volunteers who are judged inappropriate for participation to the trial by the physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisayo Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code


Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka, Osaka

TEL

06-6605-2947

Email

yokoyama@sports.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisayo Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code


Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka, Osaka

TEL

06-6605-2947

Homepage URL


Email

yokoyama@sports.osaka-cu.ac.jp


Sponsor or person

Institute

Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2013 Year 09 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2013 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 17 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

2013 Year 09 Month 12 Day

Last modified on

2018 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013504


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name