UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038627 |
|---|---|
| Receipt number | R000044023 |
| 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 | 2019/11/19 |
| Last modified on | 2020/05/19 10:42:19 |
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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.Peripheral blood test
Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP),calcitonin(CT)
*Examinations will be performed before and 4 weeks after intake of the test food.
2.calcaneus bone: SOS score, T-score, YAM score, and Z score
* Measured by quantitative ultrasound (QUS).
* Perform the test at screening.
3.Dietary assessment method
brief-type self-administered diet history questionnaire (BDHQ)
*examination before consuming and at 4 weeks after 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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
I. active food 1
II. active food 2
III. placebo food
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-III.
*Washout period is for 2 weeks and more.
Interventions/Control_2
I. active food 2
II. placebo food
III. active food 1
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-III.
*Washout period is for 2 weeks and more.
Interventions/Control_3
I. placebo food
II. active food 1
III. active food 2
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-III.
*Washout period is for 2 weeks and more.
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
48
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
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
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
***@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
| 2019 | Year | 11 | Month | 19 | 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
44
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
| 2019 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 19 | 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
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044023
