UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043857 |
|---|---|
| Receipt number | R000050061 |
| Scientific Title | Evaluation of effect of Matcha ingestion on human gut microbiota. |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/10/06 09:08:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of effect of Matcha ingestion on human gut microbiota.
Acronym
Effect of Matcha on human gut microbiota.
Scientific Title
Evaluation of effect of Matcha ingestion on human gut microbiota.
Scientific Title:Acronym
Effect of Matcha on human gut microbiota.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Matcha is traditional tea in Japan. Matcha contains polyphenols such as catechins which can affect intestinal microbiota. Additionally, drinking Matcha is expected to increase the amount of dietary fiber ingested because Matcha is grinded leaf but not leaf extract. Thus, Matcha is supposed to be effective on improving gut microbiota. In this study, effect of Matcha on gut microbiota of healthy adults was evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in gut microbiota before and after ingestion of Matcha tea.
Duration of the ingestion is at least 1 week.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A: Oral administration of Matcha (1.5g/80ml hot water) to subjects for 2 weeks.
Interventions/Control_2
B: Oral administration of Placebo (80ml of colored flavor hot water) to subjects for 2 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults without pre-existing diseases.
Key exclusion criteria
Subjects with pre-existing diseases or subjects having any medical cares.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Inoue |
| Middle name | |
| Last name | Ryo |
Organization
Kyoto Prefectural University
Division name
Division of Applied Biology
Zip code
606-8522
Address
Hangicho 1-5, Shimogamo, Sakyo-ku, Kyoto
TEL
0757035134
r-inoue@kpu.ac.jp
Public contact
Name of contact person
| 1st name | Inoue |
| Middle name | |
| Last name | Ryo |
Organization
Kyoto Prefectural University
Division name
Division of Applied Biology
Zip code
606-8522
Address
Hangicho 1-5, Shimogamo, Sakyo-ku, Kyoto
TEL
0757035134
Homepage URL
r-inoue@kpu.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Matcha and Healthy Life
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University
Address
Hangicho 1-5, Shimogamo, Sakyo-ku, Kyoto
Tel
0757035134
r-inoue@kpu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
33
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 | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 07 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050061
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
