UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056020 |
|---|---|
| Receipt number | R000064008 |
| Scientific Title | The relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition (observational study)(SBF-2024-05) |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/05/07 11:38:26 |
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Basic information
Public title
The relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition (observational study)
Acronym
The relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition (observational study)
Scientific Title
The relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition (observational study)(SBF-2024-05)
Scientific Title:Acronym
The relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition (observational study)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition
Basic objectives2
Others
Basic objectives -Others
To confirm the relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between woman's subjective physical and mental symptoms, hormones, diet and nutrition questionnaires
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Subjects who have received a thorough explanation of the purpose and content of this study, possess the capacity to consent, fully understand the information and agree to participate
(2)Adult females aged 20 to under 35 at the time of obtaining consent
(3)Subjects whose menstrual cycles are stable within the normal range
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 who have donated 200 mL or more of blood as component blood or whole blood from 4 weeks before the start of the study to the start of the study.
(4)Subjects who have collected 400 mL or more of whole blood from 16 weeks before the start of the study to the start of the study.
(5)Subjects who have collected 800 mL or more of whole blood from 12 months before the start of the study to the start of the study.
(6)Subjects currently participating in other human trials or within four weeks of completing participation in such trials
(7)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
(8)Subjects taking medicines or undergoing treatment that affect female hormones, such as pills or hormone replacement therapy
(9)Subjects with a history of mental illness or current illness who are taking medication or undergoing treatment
(10)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
(11)Subjects who have difficulty answering the questionnaire online
(12)Others who were judged as inappropriate for participation by the principal/sub investigator.
Target sample size
100
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
211-0067
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 | Yukie |
| Middle name | |
| Last name | Karasudani |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6840
Homepage URL
Yukie_Karasudani@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food limited.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2024 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To confirm the relationship between woman's subjective physical and mental symptoms, hormones, diet and nutrition
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064008
