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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019909
Receipt No. 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 2015/11/24

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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
Middle name
Last name Uenishi Kazuhiro
Organization Kagawa Nutrition University
Division name Laboratory of Physiological Nutrition
Zip code
Address 3-9-21,Chiyoda,Sakado,Saitama, 350-0288 Japan
TEL 049-284-3895
Email uenishi@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Uenishi Kazuhiro
Organization Kagawa Nutrition University
Division name Laboratory of Physiological Nutrition
Zip code
Address 3-9-21,Chiyoda,Sakado,Saitama, Japan
TEL 049-284-3895
Homepage URL
Email uenishi@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 02 Day
Last follow-up date
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
2015 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022992

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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