UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048455 |
|---|---|
| Receipt number | R000055221 |
| Scientific Title | Effect of the diet avoiding relative energy deficiency on physical condition in female long distance runners |
| Date of disclosure of the study information | 2022/07/25 |
| Last modified on | 2023/10/04 10:54:02 |
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Basic information
Public title
Effect of the diet avoiding relative energy deficiency on physical condition in female long distance runners
Acronym
A study of energy status and physical condition of female athletes
Scientific Title
Effect of the diet avoiding relative energy deficiency on physical condition in female long distance runners
Scientific Title:Acronym
A study of energy status and physical condition of female athletes
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate long-term change in physical condition of female athletes at risk of energy deficiency by eating balanced-diet that avoids relative energy deficiency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood parameters
Key secondary outcomes
Body composition, bone mineral density, organ mass, energy intake, resting energy expenditure, total energy expenditure, energy availability, eating attitude
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Provide balanced-meals for 12 months
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Female long distance runner
2. A participant who consented to the study
3. A participant who can receive dietary intervention
Key exclusion criteria
1. Smoker
2. A participant who is judged inappropriate by physician
3. A participant who is involved other dietary intervention study
4. A participant who refrain from daily training due to injury or illness
5. A participant with electrically, magnetically or mechanically activated implants in the body
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6778
mtaguchi@waseda.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6778
Homepage URL
mtaguchi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Ethics Review Committee on Research with Human Subjects, Waseda University
Address
1-104, Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2022 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055221
