UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034257
Receipt number R000039056
Scientific Title A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial
Date of disclosure of the study information 2018/10/01
Last modified on 2019/03/13 07:49:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial

Acronym

A confirmation study of improvements in bone metabolism

Scientific Title

A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial

Scientific Title:Acronym

A confirmation study of improvements in bone metabolism

Region

Japan


Condition

Condition

Healthy Japanese adult people

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effects of improvements in bone metabolism with intake of the test food

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Urinalysis
Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD)
*Examinations will be performed before and 4 weeks after intake of the test food.

Key secondary outcomes

1.Dietary assessment method
brief-type self-administered diet history questionnaire (BDHQ)
*examination before consuming and at 4 weeks after ingestion

2.The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*Perform the test at 0 week and at 1 and 2 and 3 and 4 weeks after the ingestion


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

I. Maltobionic acid containing corn syrup solid (Calcium maltobionate)
II. Placebo supplement

Duration: 4 weeks
Dose: 1 pack, once a day (4 g)
Administration: Take pack after meal with water, warm water, coffee, apple juice, or etc.

*The intervention sequence is I-II.
*Washout period is for 2 weeks and more.

Interventions/Control_2

I. Placebo supplement
II. Maltobionic acid containing corn syrup solid (Calcium maltobionate)

Duration: 4 weeks
Dose: 1 pack, once a day (4 g)
Administration: Take pack after meal with water, warm water, coffee, apple juice, or etc.

*The intervention sequence is I-II.
*Washout period is for 2 weeks and more.

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

40 years-old <=

Age-upper limit

69 years-old >=

Gender

Female

Key inclusion criteria

1. Japanese adult female

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction.

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.

3. Subjects who are allergic to the test food related products.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name OHNISHI

Organization

Chubu University

Division name

College of Bioscience and Biotechnology

Zip code

487-8501

Address

1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN

TEL

0568-51-6328

Email

mohnishi@isc.chubu.ac.jp


Public contact

Name of contact person

1st name Daiki
Middle name
Last name SUEHIRO

Organization

San-ei Sucrochemical Co., Ltd.

Division name

Research and Development Section

Zip code

478-8503

Address

24-5, Kitahama-machi, Chita-city, Aichi, JAPAN

TEL

0562-55-5197

Homepage URL


Email

daiki-suehiro@sanei-toka.co.jp


Sponsor or person

Institute

Chubu University

Institute

Department

Personal name



Funding Source

Organization

San-ei Sucrochemical 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

Chubu University Certified Review Board

Address

1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN

Tel

0568-51-1141

Email

***@isc.chubu.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

中部大学(愛知県)
Chubu University (Aichi)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 01 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

68

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

2018 Year 09 Month 21 Day

Date of IRB

2018 Year 09 Month 21 Day

Anticipated trial start date

2018 Year 10 Month 02 Day

Last follow-up date

2018 Year 12 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 25 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name