UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030042 |
|---|---|
| Receipt number | R000034305 |
| Scientific Title | Effect of green tea on bone metabolism |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2020/05/26 08:16:45 |
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Basic information
Public title
Effect of green tea on bone metabolism
Acronym
Effect of green tea on bone metabolism
Scientific Title
Effect of green tea on bone metabolism
Scientific Title:Acronym
Effect of green tea on bone metabolism
Region
| Japan |
Condition
Condition
Healthy volunteer.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epigallocatechin gallate (EGCG) and vitamin K are containded in the green tea made in Mie, which may affect on bone metabolism. We investigate the effect of tablet of green tea on bone metabolism in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigate serum BAP, TRACP-5b, uc-OC, OC and vitamin K after taking tablets for 4weeks.
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One tablet contains 0.0025mg vitamin K and 19.4mg EGCG. 15 tablets will be taken per day for 28 days. Blood examination will be conducted before and after taking tablets for 28 days.
Interventions/Control_2
15 placebo tablets will be taken per day for 28 days. Blood examination will be conducted before and after taking tablets for 28 days.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy volunteer.
Key exclusion criteria
The patient medicated with wafarin or therapeutic agents for osteoporosis or diabetes.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Sudo |
Organization
Mie University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie
TEL
0592321111
seikei@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Naito |
Organization
Mie University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
514-8507
Address
2-174 Edobashi Tsu Mie
TEL
0592321111
Homepage URL
seikei@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Graduate School of Medicine, Clinical Research Support Center
Address
2-174 Edobashi Tsu Mie
Tel
0592321111
kk-sien@mo.medic.mie-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
27028C
Org. issuing International ID_1
Ministry of Agriculture, Forestry and Fisheries of Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重県庁内会議室（三重県）、三重県農業研究所（三重県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034305
