UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059119 |
|---|---|
| Receipt number | R000067509 |
| Scientific Title | Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/10/09 15:51:19 |
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Basic information
Public title
Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods
Acronym
Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods
Scientific Title
Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods
Scientific Title:Acronym
Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of consuming the test food on temporary psychological stress and fatigue experienced in daily life during menopause.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Japanese Version (Full Item Version)
Key secondary outcomes
* Secondary evaluation items
1) Menopausal symptom evaluation form
2) OSA sleep questionnaire MA version
3) Questionnaire survey using the VAS method
4) Female hormone-related indicator tests
5) Bone marker-related indicator tests
* Safety evaluation items
1) Physical examination
2) Clinical examination
3) Physician interview/evaluation of adverse events and side effects
4) Subject diary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 capsule in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule in a day; 8 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) Women aged 40 to 59 at the time of obtaining consent to participate in the trial.
2) Individuals who are aware of symptoms associated with menopause (irritability, anxiety, mood swings, etc.).
3) Individuals who have received sufficient explanation of the purpose and content of this trial, have the capacity to consent, understand it well, voluntarily volunteer to participate, and can give written consent to participate in this trial.
4) Individuals who can visit the facility on the designated examination date and undergo the examination.
Key exclusion criteria
Individuals
1) who are suffering from any disease and undergoing treatment.
2) with a history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or a history of serious diseases.
3) with a history of severe conditions such as liver, kidney, heart, lung, blood, digestive tract, respiratory, endocrine, metabolic, neurological, or consciousness disorders.
4) with severe anemia.
5) with a Simplified Menopause Index (SMI) of 51 points or higher.
6) with a CES-D Depression Self-Rating Scale score of 16 or higher (suspected depressive state).
7) who have a history of taking or applying medication for the treatment of a disease within the past month.
8) with a BMI of 30.0 kg/m2 or higher.
9) at risk of allergic reactions to components contained in the test food, as well as individuals at risk of allergic reactions to other foods or medications.
10) with a history of continuous consumption of specific health foods, functional foods, health supplements, or dietary supplements within the past three months, as well as individuals planning to consume such products during the trial period.
11) who have undergone placenta therapy within the past three months or currently undergoing such therapy.
12) whose daily alcohol consumption exceeds an average of 20 g/day of pure alcohol per week.
13) with irregular lifestyles, such as shift work or night work.
14) who may change their lifestyle during the trial period.
15) who have had 200 mL of blood drawn within one month prior to the start of the examination, or 400 mL or more within three months prior to the start of the examination.
16) currently participating in other human clinical trials, or individuals who have participated in other human clinical trials within the past three months.
17) who are pregnant, breastfeeding, or have the possibility of becoming pregnant, or who intend to become pregnant during the trial period.
18) Other individuals deemed inappropriate for this trial by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuji |
| Middle name | |
| Last name | Takahashi |
Organization
ICHIMARU PHARCOS Co., Ltd.
Division name
Research and Development Divison
Zip code
501-0475
Address
318-1 Asagi, Motosu-Shi, Gifu
TEL
058-320-1052
support@ichimaru.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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 | 18 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stratified analysis shall be conducted based on the statistical analysis plan.
Management information
Registered date
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067509
