UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027531 |
|---|---|
| Receipt number | R000031559 |
| Scientific Title | A study for evaluating the effects of oral intake of microorganism-originated food on antivirus reaction of immune cells. |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2017/05/29 14:49:03 |
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Basic information
Public title
A study for evaluating the effects of oral intake of microorganism-originated food on antivirus reaction of immune cells.
Acronym
A study for the effects of microorganism-originated food on antivirus reaction
Scientific Title
A study for evaluating the effects of oral intake of microorganism-originated food on antivirus reaction of immune cells.
Scientific Title:Acronym
A study for the effects of microorganism-originated food on antivirus reaction
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of 4 weeks oral intake of microorganism-originated food on immune functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of immunocytes (Neutrophil phagoctytosis activities etc.)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Microorganism-originated food, 1 portion of food per day for 4 weeks.
Interventions/Control_2
Placebo (not containing microorganism-originated food), 1 portion of food per day 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged from 20 to less than 60 years old, when giving the informed consent.
2) Individuals work in daytime and do not have night shift.
3) Individuals who can avoid eating foods containing food originated from a microorganism
4) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5) Individuals who can accomplish their tasks in the study at the appointed date.
6) Individuals who are judged suitable for this study by the investigators.
Key exclusion criteria
1) Individuals who can't avoid medication which effects on the results.
2) Individuals who can't avoid functional foods which effects on the results.
3) Individuals who are pregnant or willing to be pregnant. Individuals who are breast-feeding.
4) Individuals who are enrolled in other clinical trials.
5) Individuals who have a medical history of serious hepatopathy, nephropathy, or heart disease.
6) Individuals who have a medical history of viral hepatitis.
7) Individuals who have serious anemia.
8) Individuals who have serious hay fever symptoms and cannot avoid steroidal agents.
9) Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Okada |
Organization
Namamugi hospital
Division name
Director
Zip code
Address
1-14-21 Namamugi Tsurumi Yokohama Kanagawa, Japan
TEL
045-521-1191
k.okada@namamugi-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Fujii |
Organization
Kirin Company, Limited
Division name
Research Laboratories for Health Science & Food Technologies
Zip code
Address
1-13-5 Fukuura Kanazawa Yokohama Kanagawa, Japan
TEL
045-330-9837
Homepage URL
tfujii@kirin.co.jp
Sponsor or person
Institute
Kirin Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
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
Address
Tel
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
| 2017 | Year | 05 | Month | 30 | 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
| 2014 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031559
