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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034257
Receipt No. 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

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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
Institute Chubu University
Institute
Department

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
URL(English) https://upload.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


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