UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012761 |
|---|---|
| Receipt number | R000014910 |
| Scientific Title | The effect of a serotonin in the enteric canal to NK activity by oral administration of Aureobasidium pullulanse induced beta glucan, and dose-dependency of the glucan in this effect. |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2014/06/17 18:21:38 |
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Basic information
Public title
The effect of a serotonin in the enteric canal to NK activity by oral administration of Aureobasidium pullulanse induced beta glucan, and dose-dependency of the glucan in this effect.
Acronym
The Study of NK activation effect by the Aureobasidium pullulanse induced beta glucan
Scientific Title
The effect of a serotonin in the enteric canal to NK activity by oral administration of Aureobasidium pullulanse induced beta glucan, and dose-dependency of the glucan in this effect.
Scientific Title:Acronym
The Study of NK activation effect by the Aureobasidium pullulanse induced beta glucan
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the health effects by daily intake of glucan mainly to NK cells activity. At the same time, a role of the serotonin of the enteric canal in the NK cells activity effect and requirements of the glucan are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cells activity and serotonin level in platelet before and after glucan intake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A participant eats 1 jelly containing 5 ml of glucan per day by himself and eat it for 12 weeks.
Interventions/Control_2
A participant eats 2 jelly containing 5 ml of glucan per day by himself and eat it for 12 weeks.
Interventions/Control_3
A participant eats 3 jelly containing 5 ml of glucan per day by himself and eat it for 12 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.That whose age at the time of informed consent is aged 20 and over.
2.Those who can understand the purpose and the contents of this study, and can agree with participation to this study by letter.
Key exclusion criteria
having a disease
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Shunji Mizobuchi |
Organization
Kochi University
Division name
Clinical nursing
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-866-5811
mizoshun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiya Watanabe |
Organization
Kochi University
Division name
Clinical nursing
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-880-2171
Homepage URL
y-watanabe@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kaigen Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2014 | 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
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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014910
| 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 |
