UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052021 |
|---|---|
| Receipt number | R000059380 |
| Scientific Title | A study for evaluating the immune response by ingestion of fermented plant extract |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2024/03/29 09:54:42 |
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Basic information
Public title
A study for evaluating the immune response by ingestion of fermented plant extract
Acronym
A study for evaluating the immune response by ingestion of fermented plant extract
Scientific Title
A study for evaluating the immune response by ingestion of fermented plant extract
Scientific Title:Acronym
A study for evaluating the immune response by ingestion of fermented plant extract
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the the immune response by ingestion of a fermented plant extract for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary sIgA concentration, salivary s-IgA secretion rate, POMS2, stool frequency
Key secondary outcomes
natural killer activity, OSA-MA, Analysis of the gut microbiota
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
Ingestion of fermented plant extract for 4 consecutive weeks.
Interventions/Control_2
Ingestion of placebo for 4 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healty men and women aged 18 to 64 years.
(2)A lower salivary secretory immunoglobulin A secretion rate.
(3)POMS2-AS gives priority to FI T score is high and VA T score is low.
(4)Subjects with a bowel movement frequency of 3 to 5 times per week based on the results of lifestyle questionnare and subject with fatigue and dissatisfies with sleep in everyday life.
Key exclusion criteria
(1)Subjects who use fermented plant extract containing food or food similar to fermented plant extract.
(2)Subjects routinely taking health supplements which may influence immune function.
(3)Subjects routinely taking health supplements which may influence bowel movement.
(4)Subjects taking medicine and quasi drug which may influence immune function.
(5)Subjects undergoing treatment related to fatigue, stress, and/or sleep.
(6)Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative.
(7)who are under medication which may influence the outcome of the study.
(8)Subjects having diseases affecting bowel movement or a history of these diseases.
(9)Subjects who have a history of the allergic disease.
(10)Subjects who have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care.
(11)Subjects who have oral or dental problems with bleeding.
(12)Night and day shift worker or manual laborer.
(13)Subjects who have carried out an intense activity
(14)Subjects who cannot carry out a procedure of various inspection by the rule during the study period.
(15)Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor.
(16)Subjects who have under treatment or a history of serious disease and disease to affect the adrenal cortical hormone secretion.
(17)Subjects having possibilities for emerging allergy related to the study.
(18)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(19)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(20)Subjects who are Participating in other clinical studies at the beginning of the present study.
(21)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kawase |
Organization
Miyato Yaso Institute Co., Ltd.
Division name
sales division
Zip code
944-0020
Address
7-7, Kohdan-cho, Myoko-City, Niigata Prefecture
TEL
0255-73-7189
y.kawase@miyatou.co.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center, Foods Department
Zip code
162-0821
Address
Kagurazaka AK Building, 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-1536-4583
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Miyato Yaso Institute Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
| 2023 | Year | 08 | 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
| 2023 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059380
