UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041111 |
|---|---|
| Receipt number | R000046935 |
| Scientific Title | A study for the effect of intake of test food on mood states |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2022/01/15 11:16:34 |
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Basic information
Public title
A study for the effect of intake of test food on mood states
Acronym
A study for the effect of intake of test food on mood states
Scientific Title
A study for the effect of intake of test food on mood states
Scientific Title:Acronym
A study for the effect of intake of test food on mood states
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of test food on mood states
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood states
Key secondary outcomes
Subjective cognitive function
Questionnaires
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1) Without intake of test drink, 1 week
2) Intake of test drink (350 mL/day), 3 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who fall under all of the following (1) to (3)
(1) Healthy men and women over the age of 20 when consent is obtained
(2) Those whose primary language is Japanese
(3) Those with mental fatigue
Key exclusion criteria
(1) Those who cannot consent to participate in the study in writing
(2) Those who have allergy to test foods
(3) Those who are under treatment of cranial nerve disease
(4) Those who have anamnesis of cranial nerve disease
(5) Those who and whose family is working in Kirin Holdings Company, Limited or its group companies
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kuniaki |
| Middle name | |
| Last name | Obara |
Organization
Kirin Holdings Company, Limited
Division name
Research and Development division, Kirin Central Research Institute
Zip code
236-0004
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Fukuda |
Organization
Kirin Holdings Company, Limited
Division name
Research and Development division, Kirin Central Research Institute
Zip code
236-0004
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
080-1930-9968
Homepage URL
Takafumi_Fukuda@kirin.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitsui Fudosan Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kirin Group
Address
4-10-2, Nakano, Nakano-ku, Tokyo
Tel
03-6837-4128
02976_Ni@kirin.co.jp
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
| 2021 | Year | 06 | Month | 30 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046935
