UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Different Energy Availability during Endurance Training on the Iron Metabolism
Acronym	Effect of Different Energy Availability during Endurance Training on the Iron Metabolism
Scientific Title	Effect of Different Energy Availability during Endurance Training on the Iron Metabolism -focus on the muscle glycogen-
Scientific Title:Acronym	Effect of Different Energy Availability during Endurance Training on the Iron Metabolism -focus on the muscle glycogen-
Region	Japan

Condition
Condition	Iron Deficiency
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify effect of low energy availability during training on inhibits iron metabolism via hepcidin elevation.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Blood sampling and evaluate muscle glycogen using 13C-MRS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Training under different of energy availability
Interventions/Control_2	3-days
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	19 years-old <=
Age-upper limit	22 years-old >=
Gender	Male
Key inclusion criteria	The inclusion criteria were non-anemic and >20 ng/mL of ferritin level
Key exclusion criteria	The exclusion criteria were smoking and use of herbs and medications.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Aya Middle name Last name Ishibashi
Organization	Japan Institute of Sports Sciences
Division name	Sports Medical Center
Zip code	1150056
Address	3-15-1, Nishigaoka, Kita-Ku, Tokyo
TEL	03-5963-0215
Email	aya.ishibashi@jpnsport.go.jp

Public contact
Name of contact person	1st name Aya Middle name Last name Ishibashi
Organization	Japan Institute of Sports Sciences
Division name	Sports Medical Center
Zip code	1150056
Address	3-15-1, Nishigaoka, Kita-Ku, Tokyo
TEL	03-5963-0215
Homepage URL
Email	aya.ishibashi@jpnsport.go.jp

Sponsor
Institute	Japan Institute of Sports Sciences
Institute
Department

Funding Source
Organization	Japan Institute of Sports Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Institute of Sports Sciences
Address	3-15-1, Nishigaoka, Kita-Ku, Tokyo
Tel	03-5963-0215
Email	aya.ishibashi@jpnsport.go.jp

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	2019 Year 08 Month 27 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	6
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	2017 Year 02 Month 01 Day
Date of IRB	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 27 Day
Last modified on	2019 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043120