UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054860 |
|---|---|
| Receipt number | R000062684 |
| Scientific Title | Association with physique/body composition, bone mass, and lifestyle in young women |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/07/03 11:25:21 |
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Basic information
Public title
Association with physique/body composition, bone mass, and lifestyle in young women
Acronym
Association with physique/body composition, bone mass, and lifestyle in young women
Scientific Title
Association with physique/body composition, bone mass, and lifestyle in young women
Scientific Title:Acronym
Association with physique/body composition, bone mass, and lifestyle in young women
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association with physique/body composition, bone mass, and lifestyle in young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physique (height, body weight) / body composition (muscle mass, bone mass, fat mass, lean body mass), phase angle
Key secondary outcomes
Boen mass (speed of sound, broadband ultrasound attenuation, stiffness index)
Questionnaire (lifestyle (diet, exercise, indulgences, and so on), menstrual history)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy women
Key exclusion criteria
Bone lesions
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Minematsu |
Organization
Kio University
Division name
Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
TEL
0745-54-1601
a.minematsu@kio.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Minematsu |
Organization
Kio University
Division name
Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
TEL
0745-54-1601
Homepage URL
a.minematsu@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Minematsu Akira
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
Tel
0745-54-1601
a.minematsu@kio.ac.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
| 2024 | Year | 09 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Outcome data (physique/body composition, bone mass, lifestyle, and so on) are measured and accessed again in the same subjects the next year, and we investigate the related factors that influences these changes.
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062684
