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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name