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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038470
Receipt No. R000042432
Scientific Title Clinical trial of Milk Basic Protein (MBP) on Female College athletes
Date of disclosure of the study information 2019/11/02
Last modified on 2019/11/01

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Basic information
Public title Clinical trial of Milk Basic Protein (MBP) on Female College athletes
Acronym Clinical trial of MBP on Female College athletes
Scientific Title Clinical trial of Milk Basic Protein (MBP) on Female College athletes
Scientific Title:Acronym Clinical trial of MBP on Female College athletes
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effect of MBP on female college athletes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density
Key secondary outcomes Serum; Bone type alkaline phosphatase (BAP), Osteocalcin (OC), undercarboxylated osteocalcin (ucOC)
Uline; Type I collagen cross-linked C-telopeptide (CTX), Type I collagen cross-linked N-telopeptide (NTX), Deoxy pyridinoline (DPD), iron deficiency related factor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 For group A, we will conduct Shokuiku and participants will have a calcium and protein rich diet.
Interventions/Control_2 Group B intakes 40mg of MBP after dinner for 6 months. We will conduct Shokuiku and participants will have a calcium and protein rich diet.
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 Female
Key inclusion criteria Healthy female collegiate athletes
Key exclusion criteria Cow's milk allergy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Azumi
Middle name
Last name Hida
Organization Tokyo University of Agriculture
Division name Department of Nutritional Science
Zip code 156-8502
Address 1-1-1, Sakuragaoka,Setagaya, Tokyo
TEL 03-5477-2378
Email a3hida@nodai.ac.jp

Public contact
Name of contact person
1st name Azumi
Middle name
Last name Hida
Organization Tokyo University of Agriculture
Division name Department of Nutritional Science
Zip code 156-8502
Address 1-1-1, Sakuragaoka,Setagaya, Tokyo
TEL 03-5477-2378
Homepage URL
Email a3hida@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization Tokyo University of Agriculture
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo U niversity of Agriculture
Address 1-1-1, Sakuragaoka, Setagaya, Tokyo
Tel 03-5477-2532
Email nri@nodai.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
2019 Year 11 Month 02 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
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 08 Month 28 Day
Anticipated trial start date
2019 Year 08 Month 28 Day
Last follow-up date
2021 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
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042432

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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