UMIN-CTR Clinical Trial

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
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	0362729163
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=R000043937