UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047027
Receipt number R000053650
Scientific Title Exploratory research using existing samples on the effect of yogurt intake on immune function for healthy adults
Date of disclosure of the study information 2022/03/02
Last modified on 2023/11/13 18:34:45

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Basic information

Public title

Exploratory research using existing samples on the effect of yogurt intake on immune function for healthy adults

Acronym

Exploratory research using existing samples on the effect of yogurt intake on immune function for healthy adults

Scientific Title

Exploratory research using existing samples on the effect of yogurt intake on immune function for healthy adults

Scientific Title:Acronym

Exploratory research using existing samples on the effect of yogurt intake on immune function for healthy adults

Region

Japan


Condition

Condition

N/A (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of yogurt intake on immune function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Activation status of various immune cells
Plasma cytokine levels

Key secondary outcomes



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

35 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects of the other study (UMIN000045839)

Key exclusion criteria

Subjects whose specimen have not been obtained in the other study (UMIN000045839)

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Kano

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachiouji, Tokyo, Japan

TEL

81-42-632-5842

Email

hiroshi.kano@meiji.com


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Kano

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachiouji, Tokyo, Japan

TEL

81-42-632-5842

Homepage URL


Email

hiroshi.kano@meiji.com


Sponsor or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Meiji Holdings Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Meiji Institutional Review Board

Address

1-29-1 Nanakuni, Hachiouji, Tokyo, Japan

Tel

81-42-632-5900

Email

MEIJI.IRB@meiji.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

2022 Year 03 Month 02 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

2022 Year 02 Month 17 Day

Date of IRB

2022 Year 02 Month 17 Day

Anticipated trial start date

2022 Year 03 Month 02 Day

Last follow-up date

2022 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is conducted using specimens obtained in the other study (UMIN000045839). There is no intervention and invasion in this study.


Management information

Registered date

2022 Year 02 Month 28 Day

Last modified on

2023 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053650