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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030042
Receipt No. R000034305
Scientific Title Effect of green tea on bone metabolism
Date of disclosure of the study information 2017/11/20
Last modified on 2017/11/20

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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
Middle name
Last name Sudo Akihiro
Organization Mie University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code
Address 2-174 Edobashi Tsu Mie
TEL 0592321111
Email seikei@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naito Yohei
Organization Mie University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code
Address 2-174 Edobashi Tsu Mie
TEL 0592321111
Homepage URL
Email seikei@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Mie University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 05 Month 16 Day
Last follow-up date
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
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034305

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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