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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033383
Receipt No. 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

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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
Institute TTC Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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