UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029949 |
|---|---|
| Receipt number | R000034210 |
| Scientific Title | Verification test on blood flow improvement effect by ingestion of black tea |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2018/04/05 14:23:40 |
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Basic information
Public title
Verification test on blood flow improvement effect by ingestion of black tea
Acronym
Verification test on blood flow improvement effect by ingestion of black tea
Scientific Title
Verification test on blood flow improvement effect by ingestion of black tea
Scientific Title:Acronym
Verification test on blood flow improvement effect by ingestion of black tea
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of blood flow and body surface temperature effect of ingestion of black tea
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring blood flow and body surface temperature at before cooling stress and after 10, 20 and 30 minutes after cooling stress.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Capsules containing black tea (test capsules)
Interventions/Control_2
Capsules not containing black tea (placebo capsules)
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subject
Key exclusion criteria
1) Subjects who are under medication or having a history of serious diseases for which medication was required.
2) Subjects who may be pregnant or possible pregnant.
3) Subjects who are lactating.
4) Subjects who are unsuitable for the entry judged by a doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruko Takeyama |
Organization
Waseda University (Graduate School)
Division name
Integrated Institute for Regulatory Science, Research Organization for Nano & Life Innovation
Zip code
Address
2-2, wakamatsu-cho, Shinjyuku, Tokyo
TEL
03-5369-7326
haruko-takeyama@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Takamizawa |
Organization
Waseda University (Graduate School)
Division name
Integrated Institute for Regulatory Science, Research Organization for Nano & Life Innovation
Zip code
Address
2-2, wakamatsu-cho, Shinjyuku, Tokyo
TEL
03-5369-7326
Homepage URL
takamizawa.n@aoni.waseda.jp
Sponsor or person
Institute
Waseda University (Graduate School)
Institute
Department
Personal name
Funding Source
Organization
Donated funds
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 13 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
