UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061131 |
|---|---|
| Receipt number | R000069950 |
| Scientific Title | Effects of continuous test beverage intake on menstrual-related symptoms in young women |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/01 16:27:49 |
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Basic information
Public title
Effects of continuous test beverage intake on menstrual-related symptoms in young women
Acronym
Effects of continuous test beverage intake on menstrual-related symptoms in young women
Scientific Title
Effects of continuous test beverage intake on menstrual-related symptoms in young women
Scientific Title:Acronym
Effects of continuous test beverage intake on menstrual-related symptoms in young women
Region
| Japan |
Condition
Condition
Healthy young women with menstrual-related symptoms
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of continuous intake of a test beverage during periods aligned with the menstrual cycle on menstrual-related symptoms, compared with a placebo group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total and mental symptom scores of the Menstrual Distress Questionnaire (MDQ)
Key secondary outcomes
Physical symptom score of the Menstrual Distress Questionnaire (MDQ), Sleep-related questionnaire score, and gastrointestinal symptom questionnaire score
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test beverage for two menstrual cycles
Interventions/Control_2
Continuous intake of the placebo beverage for two menstrual cycles
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Female university students aged 20-29 years
2. Residents of Japan
3. Individuals with a normal menstrual cycle (25-38 days) and menstrual duration of 3-7 days
4. Individuals experiencing discomfort symptoms from approximately 3 days before menstruation to around the third day of menstruation
Key exclusion criteria
1. Individuals with diseases requiring ongoing medical treatment or follow-up
2. Individuals who are currently taking medications on a regular basis, or who start regular medication use during the study period (including hormonal agents and oral contraceptives)
3. Individuals with gynecological diseases (e.g., secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, endometrial cancer, ovarian cancer)
4. Individuals who dislike consuming the test beverage
5. Individuals who consume the test beverage >=5 days per week or >=7 servings per week
6. Individuals who are unable to discontinue the use of health foods (including dietary supplements), foods for specified health uses (FOSHU), foods with nutrient function claims, or foods with function claims during the study period
7. Individuals who are pregnant, breastfeeding, or intending to become pregnant during the study period
8. Individuals deemed unsuitable as study participants based on responses to the background questionnaire (lifestyle questionnaire)
9. Individuals who have participated in another clinical trial within 1 month prior to obtaining informed consent
10. Individuals with a score of 60 or higher on the Self-Rating Depression Scale (SDS)
11. Individuals whose total MDQ score after menstruation is higher than that before or during menstruation in the pre-survey (MDQ)
12. Individuals deemed unsuitable as participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Unno |
Organization
Kyoritsu Women's University
Division name
Department of Food and Nutrition, Faculty of Home Economics
Zip code
101-8437
Address
2-2-1 Hitotsubashi, Chiyoda-ku, Tokyo, Japan
TEL
03-3237-2482
tunno@kyoritsu-wu.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Unno |
Organization
Kyoritsu Women's University
Division name
Department of Food and Nutrition, Faculty of Home Economics
Zip code
101-8437
Address
2-2-1 Hitotsubashi, Chiyoda-ku, Tokyo, Japan
TEL
03-3237-2482
Homepage URL
tunno@kyoritsu-wu.ac.jp
Sponsor or person
Institute
Kyoritsu Women's University
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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
Kyoritsu Women's University
Address
2-2-1 Hitotsubashi, Chiyoda-ku, Tokyo, Japan
Tel
03-3237-2482
tunno@kyoritsu-wu.ac.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 | 04 | Month | 22 | 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 | 03 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 23 | 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
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069950
