UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038557
Receipt number R000043938
Scientific Title A study for verification of Immune index by intake test food-3
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/27 10:41:49

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Basic information

Public title

A study for verification of Immune index by intake test food-3

Acronym

A study for verification of Immune index by intake test food-3

Scientific Title

A study for verification of Immune index by intake test food-3

Scientific Title:Acronym

A study for verification of Immune index by intake test food-3

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.
To compare and verify effect of test foods for each study by analyzing the meta-analysis of the Immune index verification study-1 and 2 results associated with intake 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

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

18


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 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

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



Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 01 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

18

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=R000043938


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name