UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059252 |
|---|---|
| Receipt number | R000067771 |
| Scientific Title | Research into the relationship between menstrual pain and diet: Longitudinal observational study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/02/19 15:51:41 |
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Basic information
Public title
Research into the relationship between menstrual pain and diet: Longitudinal observational study
Acronym
Research into the relationship between menstrual pain and diet: Longitudinal observational study
Scientific Title
Research into the relationship between menstrual pain and diet: Longitudinal observational study
Scientific Title:Acronym
Research into the relationship between menstrual pain and diet: Longitudinal observational study
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study targets women aged 18 to 22 years to understand the current status of menstrual pain and to clarify the relationship between pain and dietary content.
Basic objectives2
Others
Basic objectives -Others
This study aimed at investigating actual conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Menstrual pain will be assessed using questionnaires such as the NRS, and dietary surveys (MDHQ, FFQ, VDDQ-J) will be used to assess diet. The relationship between these will be evaluated over time.
Key secondary outcomes
Participants will be asked to complete a background information survey in October 2025, which will investigated to background information on birth weight, how they deal with menstruation, and their dietary experiences. In conjunction with the pain survey, medication status and menstrual flow volume and condition will be investigated. Physical measurements will also be taken in March 2026 to measure such as blood pressure and body composition. In addition, clinical tests (hematology tests, blood biochemistry tests, and urinalysis) will be conducted to examine biological parameters. Urine samples will be collected twice, once between January and February 2026 and once in March 2026, to examine parameters such as PGE-MUM and urinary protein. Biological data will be collected using wearable devices.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy women
2. Student at Kagawa Nutrition University.
3. Those who have received a sufficient explanation of this study understand it and voluntarily consent to participate.
Key exclusion criteria
1. Those currently undergoing treatment for or with a history of malignant tumors, heart failure, or myocardial infarction.
2. Individuals with an implanted pacemaker or implantable cardioverter defibrillator.
3. Individuals are currently undergoing treatment for arrhythmia, liver damage, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases.
4. Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period.
5. Individuals who have participated in other clinical research studies within the 28 days prior to the date of consent acquisition, or who plan to participate in such studies during the study period.
6. Individuals who the principal investigator deems inappropriate for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Kaneko |
Organization
Maruha Nichiro Corporation
Division name
Central Research Institute, Food Tech Research Division.
Zip code
300-4295
Address
16-2 Wadai, Tsukuba, Ibaraki, Japan.
TEL
029-864-6708
sh-kaneko@maruha-nichiro.co.jp
Public contact
Name of contact person
| 1st name | Terue |
| Middle name | |
| Last name | Kawabata |
Organization
Kagawa Nutrition University
Division name
Faculty of Nutrition
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado, Saitama, Japan.
TEL
049-282-3705
Homepage URL
kawabata@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
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
Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seishinkai Medical Corporation, Takara Clinic, Ethics Committee
Address
Taisei Building 9F, 2-3-2 Higashigotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
女子栄養大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of participants will take place from September 16th to 30th, 2025. Participants will be selected from those who wish to participate in this study and who meet the selection criteria.
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067771
