UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060298 |
|---|---|
| Receipt number | R000068975 |
| Scientific Title | An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study- |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2026/01/08 14:01:51 |
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Basic information
Public title
An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study-
Acronym
An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators.
Scientific Title
An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study-
Scientific Title:Acronym
An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratory verify the effects of the test food on mood indicators by continuously ingesting the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Japanese version
Key secondary outcomes
Fatigue VAS,State-Trait Anxiety Inventory-Form JYZ (STAI),Oguri-Shirakawa-Azumi Sleep Inventory MA version
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food A for 4 weeks
Interventions/Control_2
Intake of test food B for 4 weeks
Interventions/Control_3
Intake of control food for 4 weeks
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
1)Japanese males and females aged of 20-64 years.
2)Subjects who defecate 2-5 times from the screening test per week.
3)Subjects who can drink coffee every day
4)Subjects who can visit the study site on the scheduled date
5)Subjects who recognize the object and contents of the study and submit the written informed consent.
Key exclusion criteria
1)Subjects who regularly use laxatives or antibiotics
2)Subjects with a history or current history of serious diseases such as heart, liver, kidney, cancer, or tuberculosis (including cases of complications of other diseases)
3)Subjects who are currently receiving medication for illness or injury at the time of screening (excluding those prescribed medication for transient symptoms such as colds or hay fever) or who are scheduled to undergo surgery during the study period
4)Subjects who regularly use medicines, quasi-drugs, health foods and supplements (such as capsules) affecting the study.
5)Subjects who are shift workers or graveyard shift workers.
6)Subjects with extremely irregular daily habits and eating habits.
7)Subjects who will experience major changes in their living environment (such as moving, relocation, etc.) during the study period
8)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) or smokers.
9)Subjects who have ever felt unwell due to blood sampling.
10)Subjects who may have allergic symptoms to the test food
11)Subjects who donated 200 mL or more of blood within 1 month from the screening test or who are scheduled to do so during the study period
12)Subjects already participating in other clinical trials or who plan to participate in other clinical trials between the time of obtaining consent for this study and the final examination
13)Pregnant, breastfeeding, or likely to become pregnant during the study period
14)Subjects who are ineligible due to physician's judgment.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
Trans Genic Inc.
Division name
Clinical Research Department
Zip code
061-1405
Address
452-1 Toiso,Eniwa,Hokkaido,Japan
TEL
0123-34-0412
Homepage URL
toyotada.ashino@transgenic.co.jp
Sponsor or person
Institute
AJINOMOTO AGF, INC.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO AGF, INC.
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
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068975
