UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019909 |
|---|---|
| Receipt number | R000022992 |
| Scientific Title | Effect of milk basic protein on bone mineral density, bone metabolism in young adult women, |
| Date of disclosure of the study information | 2016/08/30 |
| Last modified on | 2023/01/13 15:32:09 |
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Basic information
Public title
Effect of milk basic protein on bone mineral density, bone metabolism in young adult women,
Acronym
Effect of milk basic protein on bone mineral density, bone metabolism.
Scientific Title
Effect of milk basic protein on bone mineral density, bone metabolism in young adult women,
Scientific Title:Acronym
Effect of milk basic protein on bone mineral density, bone metabolism.
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of bone metabolism, increase bone density
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum pentosidine, homocysteine, osteocalcin, under-carboxylated osteocalcin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
MBP 0mg/day
Interventions/Control_2
MBP 20mg/day
Interventions/Control_3
MBP 40mg/day
Interventions/Control_4
MBP 80mg/day
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
| 22 | years-old | > |
Gender
Female
Key inclusion criteria
Normal
Key exclusion criteria
Heavily or patient
In pregnancy, Possibility of pregnancy
Milk-allergic patient
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kazuhiro |
Organization
Kagawa Nutrition University
Division name
Laboratory of Physiological Nutrition
Zip code
350-0288
Address
3-9-21,Chiyoda,Sakado,Saitama, 350-0288 Japan
TEL
049-284-3895
uenishi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Uenishi |
Organization
Kagawa Nutrition University
Division name
Laboratory of Physiological Nutrition
Zip code
350-0288
Address
3-9-21,Chiyoda,Sakado,Saitama, Japan
TEL
049-284-3895
Homepage URL
uenishi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Kagawa Nutrition University
Address
3-9-21,Chiyoda,Sakado,Saitama, Japan
Tel
049-289-6041
kenshien@eiyo.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
| 2016 | 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
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022992
