UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060715 |
|---|---|
| Receipt number | R000069460 |
| Scientific Title | A study to evaluate the effects on mood states in middle-aged and elderly women |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/02/20 16:52:20 |
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Basic information
Public title
A study to evaluate the effects on mood states in middle-aged and elderly women
Acronym
A study to evaluate the effects on mood states in middle-aged and elderly women
Scientific Title
A study to evaluate the effects on mood states in middle-aged and elderly women
Scientific Title:Acronym
A study to evaluate the effects on mood states in middle-aged and elderly women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will examine the effects of 12 weeks of continuous intake of test foods on mood states in Japanese women aged 40 to 60.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Adult Short Version [Tension-Anxiety (TA)] T-Score
Key secondary outcomes
(Secondary outcomes)
POMS2 Adult Short Form TMD T-score, POMS2 Adult Short Form T-score (excluding TA), SMI
(Safety evaluation)
Adverse events
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 12 weeks
Interventions/Control_2
Intake of the placebo food for 12 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Japanese women aged 40 to 60 years old at the time of obtaining online consent.
2.Subjects with a T-score of 50 or higher for the Tension-Anxiety (TA) component of the POMS2 Adult Short Version and a total score of 50 or lower on the SMI.
3.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 been diagnosed with menopausal symptoms by a physician.
2.Subjects who are taking medication or under medical therapy.
3.Subjects who are under exercise therapy or dietetic therapy.
4.Subjects with current or history of drug dependence or alcohol dependence.
5.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.
6.Subjects with irregular life rhythms due to night shifts or shift work.
7.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
8.Subjects who drink excessive alcohol or those at risk of becoming excessive drinkers.
9.Subjects who have an extremely unbalanced diet.
10.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, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases.
11.Subjects using health foods, supplements, or medications that affect mental status (anxiety, tension, depression, etc.), the central nervous system, or menopausal symptoms (e.g., anti-anxiety drugs, antidepressants, sleeping pills, first-generation antihistamines, hormone preparations, equol-containing foods, St. John's wort, GABA, theanine, etc.).
*These are examples only, and are not limited to these.
12.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.
13.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.
14.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Inai |
Organization
FUJI SANGYO CO.,LTD
Division name
Research and Development Center
Zip code
763-0071
Address
1301, Tamura-cho, Marugame-shi, Kagawa 763-8603 Japan
TEL
0877-25-3221
inai@fuji-sangyo.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
MIS Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUJI SANGYO CO.,LTD
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 DiaStep Ouchinodoctor Research Ethics Committee
Address
Morizumi Bldg. 3F, 4-22-7 Taishido, Setagaya-ku, Tokyo, 154-0004, Japan
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 | 03 | Month | 23 | 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 | 02 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
15.Subjects who have difficulty observing records on various survey forms.
16.Subjects who are judged as an inappropriate candidate according to the screening data.
17.Subjects who are considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069460
