UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061893 |
|---|---|
| Receipt number | R000070752 |
| Scientific Title | A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators |
| Date of disclosure of the study information | 2026/07/22 |
| Last modified on | 2026/06/12 17:41:57 |
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Basic information
Public title
A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators
Acronym
A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators
Scientific Title
A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators
Scientific Title:Acronym
A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the effects of continuous consumption of the test food over a 4-week period on mental health-related indicators among Japanese men aged 30 to 59.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Adult Short Version
Key secondary outcomes
(Secondary Endpoints)
Mental health-related indicators,Specialized blood tests(cortisol, BDNF, hs-CRP, DHEA-S, serum oxytocin),Urinary metabolite analysis(urinary metabolome analysis)
/The study will be conducted when deemed necessary within the scope of the study objectives, based on a comprehensive evaluation of the results of the primary and other endpoints of the study.
(Safety evaluation items)
Physical measurements,Vital signs,Blood biochemistry tests,Hematological tests,Urinalysis,Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Intake of active food - Washout period- Intake of placebo food
Interventions/Control_2
Intake of placebo food - Washout period - Intake of active food
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Japanese men aged 30 to 59 at the time of obtaining written consent
2.Subjects with a T-score of less than 50 on the Friendship (F) scale of the POMS 2 Adult Short Form in the primary screening (SCR).
3.Subjects with a free testosterone level of 11.8 pg/mL or higher in the secondary screening (SCR).
4.Subjects with a total score of less than 10 on the PHQ-9 in the secondary screening (SCR).
5.Subjects who live with family members or a partner.
6.Subjects who are employed and engaged in desk work.
7.Subjects who have not experienced major life events such as bereavement or divorce within the past six months.
8.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Key exclusion criteria
1.Subjects who have severe mental disorders.
2.Subjects who have a history of testosterone treatment.
3.Subjects who are taking medication or under medical treatment.
4.Subjects who are under exercise therapy or dietetic therapy.
5.Subjects with current or history of drug dependence or alcohol dependence.
6.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
7.Subjects with irregular life rhythms due to night shifts or shift work.
8.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
9.Subjects who have an extremely unbalanced diet.
10.Subjects who have a smoking habit (i.e., those who have smoked within the past year).
11.Subjects with heavy alcohol consumption.(Subjects whose average daily net alcohol intake exceeds approximately 60 g)
12.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, or other metabolic diseases.
13.Subjects who are using dietary supplements, health foods, or medications that may affect mental status.
14.Subjects who are expected to experience major changes or high levels of stress in their home or work environment during the study period (e.g., job change, relocation, marriage).
15. Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
16.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kyouko |
| Middle name | |
| Last name | Shimadu |
Organization
Nippon Co., Ltd.
Division name
Central Research Institute, Innovation Center, Functional Materials Team
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
MIS Co.,Ltd.
Division name
Clinical Development Department
Zip code
531-0072
Address
8F,Sho-rei Building, 3-4-14 Toyosaki, Kitaku, Osaka-Shi, Osaka 531-0072, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
DiaStep Medical Corporation Home Doctor Clinical Research Ethics Review
Address
Morizumi Building 3F, 22-7 Taishido 4-chome, Setagaya-ku, Tokyo
Tel
03-5433-3255
tomohisa.kato@diastep.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 | 07 | Month | 22 | 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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
17.Subjects who have difficulty observing records on various survey forms.
18.Subjects who are judged as an inappropriate candidate according to the screening data.
19.Subjects who are considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2026 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070752
