UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049031 |
|---|---|
| Receipt number | R000053444 |
| Scientific Title | A clinical study on effect of EGC of cold-brew tea on immune function -a randomized, placebo controlled, double blind, parallel-group comparison clinical test- |
| Date of disclosure of the study information | 2022/09/28 |
| Last modified on | 2023/03/30 09:23:20 |
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Basic information
Public title
A clinical study on effect of EGC of cold-brew tea on immune function
-a randomized, placebo controlled, double blind, parallel-group comparison clinical test-
Acronym
A clinical study on effect of EGC of cold-brew tea on immune function
-a randomized, placebo controlled, double blind, parallel-group comparison clinical test-
Scientific Title
A clinical study on effect of EGC of cold-brew tea on immune function
-a randomized, placebo controlled, double blind, parallel-group comparison clinical test-
Scientific Title:Acronym
A clinical study on effect of EGC of cold-brew tea on immune function
-a randomized, placebo controlled, double blind, parallel-group comparison clinical test-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect on immune function and safety of continuous intake of test food for 4 weeks in the healthy Japanese males and females aged between 50 and less than 75.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire for physical condition and stress
Key secondary outcomes
Blood immune index
Immune cell profiling
Immune index of saliva
Oral flora
Intestinal flora
Body temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
The test food tea bag is brewed with water in a 400 mL bottle and drink it as a daily dose for 4 weeks.
Interventions/Control_2
The placebo food tea bag is brewed with water in a 400 mL bottle and drink it as a daily dose for 4 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 50 and less than 75 years old.
2. Japanese males and females
3. Those who can input their own data into the electronic diary.
4. Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Those who are receiving any types of medicines and/or Chinese medical treatment except a dose of medicine taken only once.
2. Those who have medical treatments such a diet therapy and/or an exercise therapy.
3. Those who had been experiencing a severe disease.
4. Those who currently have or have history of allergic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis.
5. Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial.
6. Those who have currently been taking yogurts, Lactobacillus or Bifidobacterium containing foods or beverage.
In the case of beverage type or solid type, it is applicable if it is 50g/day or more. In the case of tablet or capsule type, it is applicable if it is ingested more than once specified by the sales company.
7. Those who have currently been taking cold-brew tea.
8. Those who have a drug/food allergy.
9. Those who drink more than 60 g alcohol/day.
10. Those who have excessive smoking habits (21 or more cigarettes / day).
11. Those who work on night shift jobs and the shiftwork.
12. Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period.
13. Those who are planning to travel abroad during the study period.
14. Those who have joined other clinical trials in the past 1 month before receiving informed consent in this study, or are currently joining other clinical trials, or are planning to join other clinical trials.
15. Those who are unsuitable for this trial that judged by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Human Immunology and Nutrition Science
Zip code
602-0857
Address
Nakamitama-cho, Seiwainguchi teramachi higashi iru, Kyoto-shi, Kyoto
TEL
075-251-5124
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Department of Human Immunology and Nutrition Science
Institute
Department
Personal name
Funding Source
Organization
Agriculture, Forestry and Fisheries Research Promotion Project Consignment Project Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
Institute of Fruit Tree and Tea Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, 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
| 2022 | Year | 09 | Month | 28 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053444
| 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 |
