UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of acute exercise on diet-induced thermogenesis: potential contribution of irisin, a protein derived from skeletal muscle
Title of the study (Brief title)	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	Hisayo Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
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	Hisayo Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Address	3-3-138, Sugimoto, Sumiyoshi-ku, Osaka, Osaka
TEL	06-6605-2947
Homepage URL
Email	yokoyama@sports.osaka-cu.ac.jp

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

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 08 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013504