UMIN-CTR Clinical Trial

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
Email	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
Email	r-inoue@kpu.ac.jp

Sponsor
Institute	Kyoto Prefectural University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050061