UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038556 |
|---|---|
| Receipt number | R000043937 |
| Scientific Title | A study for verification of Immune index by intake test food-2 |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/03/27 10:39:56 |
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Basic information
Public title
A study for verification of Immune index by intake test food-2
Acronym
A study for verification of Immune index by intake test food-2
Scientific Title
A study for verification of Immune index by intake test food-2
Scientific Title:Acronym
A study for verification of Immune index by intake test food-2
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effect on the specific antibody titer production of Influenza vaccine strain by continuous intake of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Influenza vaccine antibody titer (Type A,Type B), and NK Cell activity
Key secondary outcomes
Triglycerides,totalcholesterol,HDL cholesterol,LDLcholesterol,The subject questionnaire regarding QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of study food for 12 weeks
Interventions/Control_2
Ingestion of control food substance for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects of both sexes above 20 years old- under 64 years old.
2) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria
1) Subjects who have serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, metabolic system.
2) Subjects who are under medication (especially subject who take warfarin) on a steady basis or history of medication for serious disorders.
3) Subjects who are under treatment for digestive system and Immune system disease (Autoimmune diseases, etc.) that effects on this study, or have previous history, or have history of operation on digestive system.
4) Subjects who regularly intake food with health-promoting benefits function or supplements that may possibly effect on the immunity.
5) Subjects work irregular hours on the night shift or irregular shift.
6) Subjects who smoke excessively and drink alcohol regularly.
7) Subjects with irregular lifestyle habit such as diet meal and sleep.
8) Subjects who had made blood donation within 4 weeks.
9) Subjects with history of sensitivity to the ingredients of test food.
10) Pregnant, lactating women or willing to be pregnancy during the study.
11) Subjects who participated in other monitoring study within 1 month prior to obtaining informed consent.
12) Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator or sub-investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
euglena Co., Ltd.
Division name
Advanced Technology Research Department Functionality Research Section
Zip code
108-0014
Address
Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL
0334534907
nakashima@euglena.jp
Public contact
Name of contact person
| 1st name | shigeru |
| Middle name | |
| Last name | imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
105-0004
Address
Shinbashi 2-16-1 Minato-ku,Tokyo 105-0004,Japan
TEL
08072900404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Clinical Trial Department
Institute
Department
Personal name
Funding Source
Organization
euglena Co., Ltd.
Advanced Technology Research Department Functionality Research Section
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
Mibyou Reserch Square Association
Address
2-18-4 kanda-misakicho chiyoda-ku, Tokyo, Japan
Tel
0362729163
imai@levbrain.com
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
茅場町こころのケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
12
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
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Completed
Management information
Registered date
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043937
