UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051150 |
|---|---|
| Receipt number | R000058299 |
| Scientific Title | Study of the test food on bone metabolism in healthy subjects. |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/07/02 11:21:32 |
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Basic information
Public title
Study of the test food on bone metabolism in healthy subjects.
Acronym
Study of the test food on bone metabolism in healthy subjects.
Scientific Title
Study of the test food on bone metabolism in healthy subjects.
Scientific Title:Acronym
Study of the test food on bone metabolism in healthy subjects.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of ingestion of the test food on bone in male college athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone metabolic markers
Key secondary outcomes
Bone mineral density, Blood biochemical tests, Visual Analog Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (for 8 weeks)
Interventions/Control_2
Ingestion of test food (for 8 weeks)
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
The University of Tsukuba Athletics Department Head Men's Distance Part will be requested to recruit students belonging to the department orally and in writing using the mechanism method, and those who agree to participate in the study will be selected.
Key exclusion criteria
No chronic physical diseases, food allergies or smoking habits, and have not already been exposed to more than 1 mSv of X-rays within the past year.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sports Sciences
Zip code
305-8574
Address
1-1-1, Tennoudai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-6319
omi.naomi.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sports Sciencs
Zip code
305-8574
Address
1-1-1, Tennoudai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-6319
Homepage URL
omi.naomi.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Naomi Omi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kameda Seika CO., LTD.
Name of secondary funder(s)
Kameda Seika CO., LTD.
IRB Contact (For public release)
Organization
Research ethics committee, Faculty of Health and Sport Sciences, University of Tsukuba
Address
1-1-1, Tennoudai, Tsukuba City, Ibaraki Prefecture
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.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 | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058299
