UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033383
Receipt number R000038061
Scientific Title A study to evaluate the effect of food ingredient in adult males and females on the immune system.:A randomized, double-blind, placebo controlled trial
Date of disclosure of the study information 2018/07/15
Last modified on 2018/07/13 15:41:05

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Basic information

Public title

A study to evaluate the effect of food ingredient in adult males and females on the immune system.:A randomized, double-blind, placebo controlled trial

Acronym

To evaluate the effect of food ingredient on the immune system

Scientific Title

A study to evaluate the effect of food ingredient in adult males and females on the immune system.:A randomized, double-blind, placebo controlled trial

Scientific Title:Acronym

To evaluate the effect of food ingredient on the immune system

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Cardiology Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of food ingredient on the immune system.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire

Key secondary outcomes

Immune function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of food ingredient

Interventions/Control_2

Ingestion of placebo

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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Males and females from 20 to 64 years of age
(2)Subjects whose QOL questionnaire is low
(3)Subjects who meets the criteria of inspection value in preliminary inspection
(4)Subjects who are judged as healthy males and females by the investigator

Key exclusion criteria

(1)Subjects who constantly use supplements and/or functional foods .
(2)Subjects who constantly use medicines affecting the test results.
(3)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasunobu Masuda

Organization

Kewpie Corporation

Division name

R&D Division

Zip code


Address

2-5-7, Sengawa-cho, Chofu-shi, Tokyo

TEL

03-5384-7759

Email

yasunobu_masuda@kewpie.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mariko Oe

Organization

Kewpie Corporation

Division name

R&D Division

Zip code


Address

2-5-7, Sengawa-cho, Chofu-shi, Tokyo

TEL

03-5384-7759

Homepage URL


Email

mariko_oe@kewpie.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kewpie Corporation

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


Address


Tel


Email



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

2018 Year 07 Month 15 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

Preinitiation

Date of protocol fixation

2018 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2018 Year 07 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 13 Day

Last modified on

2018 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name