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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033271
Receipt No. R000037932
Official scientific title of the study A study to evaluate the effect of food ingredient on the immune system.
Date of disclosure of the study information 2018/07/09
Last modified on 2018/07/25

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Basic information
Official scientific title of the study A study to evaluate the effect of food ingredient on the immune system.
Title of the study (Brief title) A study to evaluate the effect of food ingredient on the immune system.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of food ingredient on the immune system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune function
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 food ingredient-containing beverage
Interventions/Control_2 food ingredient-free beverage
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 Males and females aged 20 to less than 65 years old.
Key exclusion criteria (1) Subjects who constantly use supplements and/or functional foods affecting the immune system.
(2) Subjects who constantly use medicines affecting the test results.
(3) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
(4) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 220

Research contact person
Name of lead principal investigator Takanori Teramoto
Organization Suntory Beverage & Food Limited
Division name Development & design department
Address 13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL 050-3182-6114
Email Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person Eiji Fukushima
Organization Suntory Beverage & Food Limited
Division name Development & design department
Address 13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL 050-3182-0544
Homepage URL
Email Eiji_Fukushima@suntory.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 09 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037932

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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