UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033271 |
|---|---|
| Receipt number | R000037932 |
| Scientific Title | 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 | 2019/01/07 12:33:42 |
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Basic information
Public title
A study to evaluate the effect of food ingredient on the immune system.
Acronym
A study to evaluate the effect of food ingredient on the immune system.
Scientific Title
A study to evaluate the effect of food ingredient on the immune system.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takanori Teramoto |
Organization
Suntory Beverage & Food Limited
Division name
Development & design department
Zip code
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
050-3182-6114
Takanori_Teramoto@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Fukushima |
Organization
Suntory Beverage & Food Limited
Division name
Development & design department
Zip code
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
050-3182-0544
Homepage URL
Eiji_Fukushima@suntory.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2018 | Year | 06 | Month | 28 | Day |
Date of IRB
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
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037932
