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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038555
Receipt No. R000043936
Scientific Title A study for verification of Immune index by intake test food-1
Date of disclosure of the study information 2020/03/31
Last modified on 2020/03/27

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Basic information
Public title A study for verification of Immune index by intake test food-1
Acronym A study for verification of Immune index by intake test food-1
Scientific Title A study for verification of Immune index by intake test food-1
Scientific Title:Acronym A study for verification of Immune index by intake test food-1
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 03-3453-4907
Email 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
Email imai@levbrain.com

Sponsor
Institute Leverage Brain Inc.
Clinical Trial Department
Institute
Department

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 03-6272-9163
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043936

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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