UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037815 |
|---|---|
| Receipt number | R000043120 |
| Scientific Title | Effect of Different Energy Availability during Endurance Training on the Iron Metabolism -focus on the muscle glycogen- |
| Date of disclosure of the study information | 2019/08/27 |
| Last modified on | 2019/08/27 14:52:16 |
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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
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
aya.ishibashi@jpnsport.go.jp
Sponsor or person
Institute
Japan Institute of Sports Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043120
