UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038470
Receipt number 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 2023/08/15 11:52:46

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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 or person

Institute

Tokyo University of Agriculture

Institute

Department

Personal name



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

23

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

2024 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

2023 Year 08 Month 15 Day



Link to view the page

Value
https://center6.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