UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042909 |
|---|---|
| Receipt number | R000045389 |
| Scientific Title | Study on improvement of digestive tract environment by green tea catechin |
| Date of disclosure of the study information | 2021/01/06 |
| Last modified on | 2025/01/08 12:41:56 |
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Basic information
Public title
Examination on the effect of green tea catechin on improvement of digestive tract environment
Acronym
Green tea catechin and environment of digestive tract
Scientific Title
Study on improvement of digestive tract environment by green tea catechin
Scientific Title:Acronym
Green tea catechin and environmental improvement in digestive tract
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A catechin intake test will be conducted in healthy subjects to analyze the oral bacterial flora, intestinal bacterial flora, and intestinal / urinary metabolites before and after catechin intake. From this study, we will clarify the effects of catechin on the digestive tract via human oral and intestinal bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the change of oral bacteria and fecal bacteria before and after catechin intake by 16S rRNA metagenomic analysis by Illumina Miseq.
Key secondary outcomes
Bile acids and short-chain fatty acids in the stool before and after ingestion, and urinary metabolites are measured before and after catechin intake as metabolites of intestinal bacteria.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
"Catechin" powder (Sanphenon EGCg-OP: manufactured and sold as a supplement by Taiyo Kagaku) is used. The EGCg intake is set to 300 mg / day and the intake period is 4 weeks (28 days).
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. An adult (regardless of gender) who can obtain a written consent to participate in the research from the person himself / herself.
2. Those who are between the ages of 50 and 70 at the time of obtaining consent (regardless of gender)
3. Those who can comply with the following lifestyle habits during the test period from one week before the start of the test
Do not consume green tea.
Do not consume many foods with high polyphenol content such as chocolate.
Do not take antibiotics.
Do not use mouthwash or mouthwash.
Refrain from taking probiotics (mainly yogurt).
Do not take natto.
Do not smoke
Do not take prebiotics (dietary fiber and oligosaccharide supplements).
Key exclusion criteria
1. Those who are treating diseases that affect the research results (dental and oral diseases, digestive diseases, etc.)
2. Those who have an extremely irregular diet
3. Those who drink a lot of green tea and alcohol on a daily basis
4. Those who habitually engage in strenuous exercise such as marathons
5. Currently, under the guidance of a doctor, those who are or will be doing exercise therapy / diet therapy
6. Serious heart disease [heart failure, myocardial infarction, myocarditis, etc.], liver disease [liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), urinary poisoning Disease, hydronephrotic syndrome], neurological disease, psychiatric disease, malignant tumor disease, etc., and those who have general condition problems
7. Those who have participated in other clinical trials within one month before obtaining consent or who plan to participate in other clinical trials during the trial period.
8. In addition, those who are judged by the investigator to be inappropriate for the study (the risk to the study subject may increase or sufficient data may not be obtained).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
TEL
075-251-5519
Homepage URL
ynaito@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory of Animal Science, Setsunan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Ethnical Review Board
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan
Tel
075-251-5337
rinri@koto.kpu-m.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 | 01 | Month | 06 | 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
40
Results
In the subjective physical condition questionnaire, which was the primary endpoint, the number of symptomatic days was statistically significantly lower in the active sencha tea group compared to the placebo hojicha group.
Results date posted
| 2024 | Year | 03 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because other analysis details are required.
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Healthy Japanese men and women aged 50 to under 75
Participant flow
Healthy Japanese men and women aged 50 to under 75 will consume the research food for 4 weeks to verify the effectiveness and safety of the research ingredients on immune function.
Research method: A double-blind parallel group comparative study will be conducted in this study. Forty Japanese research subjects eligible to participate in this study were randomly assigned in a 1:1 ratio to a test food intake group and a placebo food intake group to evaluate the efficacy and safety of the research ingredients on immune function. investigate.
Adverse events
Outcome measures
Plan to share IPD
(1) Primary endpoint: Questionnaire regarding physical condition (2) Secondary endpoints: Blood immune index, immune cell profiling, blood cytokine concentration, IgA (saliva), oral flora, intestinal flora, body temperature.
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 30 | Day |
Other
Other related information
1. Statistical analysis method
Metagenomic analysis is performed in bacterial flora analysis. As a specific analysis method, the next-generation sequencer (NGS) analysis of the V3-V4 region of the 16S rRNA gene was performed on the intestinal flora using the collected feces, and the phylum-genus level of various intestinal flora was performed. The analysis will be performed using a pipeline for NGS data analysis consisting of five bioinformatics programs containing USEARCH (Edgar, 2010), QIIME (Caporaso et al. 2010), PICRUSt (Langille et al. 2013), FishTaco (Manor and Borenstein, 2017), and Phylloseq(McMurdie and Holms, 2013).
2. Cancellation of clinical trials
2-1. Occurrence of adverse events
If the investigator determines that the subject's clinical research continuation is not appropriate due to the occurrence of adverse events, the subject's clinical research will be immediately discontinued. If the clinical study is discontinued, the investigator will evaluate the association with the study food, record it along with the reason for discontinuation, and promptly notify the subject.
2-2. Subject's offer
If the subject's request discontinues participation or continuation of clinical research regardless of whether or not it is related to clinical research, including the person's free will, accidental accident, or illness, the investigator will discontinue the clinical research of that subject. ..
2-3. Not eligible for clinical trials
If it is found that the subject is not eligible for this clinical study after the start of the clinical study, or if it is found that the necessary evaluations, observations, tests, etc. cannot be performed due to the convenience of the subject after the start of the clinical study. Immediately discontinue the subject's clinical study and promptly notify the subject.
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045389
