UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055492 |
|---|---|
| Receipt number | R000063406 |
| Scientific Title | Study of the test-food consumption on bone metabolism in women |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2024/12/10 13:19:13 |
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Basic information
Public title
Study of the test-food consumption on bone metabolism in women
Acronym
Study of the test-food consumption on bone metabolism in women
Scientific Title
Study of the test-food consumption on bone metabolism in women
Scientific Title:Acronym
Study of the test-food consumption on bone metabolism in women
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the eff ects of ingestion of the test food on bone in women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone metabolic markers
Key secondary outcomes
BMD bone-quality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
intake of test-food (12W or 24W)
Interventions/Control_2
pracebo intake(12W or 24W)
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
women
Key exclusion criteria
Those who have been diagnosed with osteoporosis by a physician
Those who have an extremely irregular lifestyle in terms of eating, sleeping, etc.
Those who have an extremely picky eater.
Those who use or are unable to refrain from using medicines, health foods, supplements, etc. (calcium, vitamin D, etc.) that affect bone function.
Persons who regularly use medicines, health foods, supplements, etc. that contain or are fortified with foods high in calcium.
Persons who have donated more than 200 mL of blood within one month or more than 400 mL within three months of the date of consent.
Those who are currently pregnant or lactating, or who may become pregnant or lactating during the study period.
Persons who have difficulty in complying with the recording of various questionnaires
Persons who are judged to be unsuitable as research subjects based on clinical laboratory values or measurements at the time of Pre measurement.
Those who have already been exposed to 1 mSv or more of X-rays within the past year.
Other subjects who are deemed inappropriate as research subjects by the physician in charge of the research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | OMI |
Organization
Univ.Tsukuba
Division name
Institute of health and Sport sciences
Zip code
305-8574
Address
Tsukuba-city Tennodai 1-1-1
TEL
0298536319
omi.naomi.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | OMI |
Organization
Univ.Tsukuba
Division name
Institute of health and SPORTS
Zip code
305-8574
Address
Tsukuba city Tennodai 1-1-1
TEL
0298536319
Homepage URL
omi.naomi.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
Univ.Tsukuba
Institute
Department
Personal name
Naomi OMI
Funding Source
Organization
Japan sicece and technoligy ergency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kamedaseika Co.,LTD.
Name of secondary funder(s)
Kamedaseika Co.,LTD.
IRB Contact (For public release)
Organization
Research Ethics Committee, Department of Physical Education, Tsukuba University
Address
Tsukuba-city Tennodai 1-1-1
Tel
0298532571
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
| 2026 | Year | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063406
