UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059059 |
|---|---|
| Receipt number | R000067395 |
| Scientific Title | Study on the effects of test foods on mental health |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/11 16:16:40 |
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Basic information
Public title
Study on the effects of test foods on mental health
Acronym
Study on the effects of test foods on mental health
Scientific Title
Study on the effects of test foods on mental health
Scientific Title:Acronym
Study on the effects of test foods on mental health
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test food on salivary hormone levels and mood in healthy adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin
Key secondary outcomes
Salivary serotonin, salivary chromogranin A, salivary cortisol, VAS happiness, EACL, MDQ, Subjective questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Single administration of test food1.
Interventions/Control_2
Single administration of test food2.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Female subjects ranging in age from 20 to 40 at informed consent.
(2) Subjects who can make self-judgment and voluntarily gave informed consent.
(3) Subjects who can track their menstrual cycle for at least the past three months using app or similar tools.
(4) Subjects whose menstrual cycle is between 25 and 38 days
Key exclusion criteria
(1) Subjects whose systolic blood pressure is less than 90 mmHg
(2) Subjects who are pregnant (including those who may be pregnant) or breastfeeding
(3) Subjects currently participating in other human trials or within four weeks of completing participation in such trials
(4) Subjects who fall under any of the following items:
a) Subjects with diseases of the heart, liver, or kidneys (including those as complications of other diseases)
b) Subjects with a history of cardiovascular disease
c) Subjects who have diabetes
d) Subjects with a history of serious diseases such as cancer and tuberculosis
(5) Subjects who are receiving medical treatment or medication
(6) Subjects having a habit of smoking.
(7) Subjects who consume more than 60 g of pure alcohol per day on average
(8) Subjects having irregular eating habits.
(9) Subjects with irregular life rhythm (e.g., irregular shift work).
(10) Subjects taking medicines or undergoing treatment that affect female hormones, such as pills or hormone replacement therapy
(11) Subjects with a history of mental illness.
(12) Subjects who plan to make significant changes to their lifestyle (eating, sleeping, exercise habits, etc.) during the exam period, such as taking a long trip.
(13) subjects who take healthy foods including soy isoflavones.
(14) Others who were judged as inappropriate for participation by the principal/sub investigator.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tanaka |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0114
Yasuhiro_Tanaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Matsuoka |
Organization
Suntory beverage & Food limited.
Division name
Suntory beverage & Food limited.
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-0550
Homepage URL
Kaori_Matsuoka@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food limited.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2025 | Year | 09 | Month | 11 | 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 | 09 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067395
