UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059159 |
|---|---|
| Receipt number | R000067667 |
| Scientific Title | The effect of intake of food components that affect intestinal and oral factors on menstrual-related complaints in young women - A randomized, single-blind, placebo-controlled, parallel-group comparative study - |
| Date of disclosure of the study information | 2025/09/22 |
| Last modified on | 2025/09/22 11:17:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect of test food intake on menstrual-related symptoms
Acronym
Examination of the effect of test food intake on menstrual-related symptoms
Scientific Title
The effect of intake of food components that affect intestinal and oral factors on menstrual-related complaints in young women - A randomized, single-blind, placebo-controlled, parallel-group comparative study -
Scientific Title:Acronym
The effect of intake of food components that affect intestinal and oral factors on menstrual-related complaints in young women - A randomized, single-blind, placebo-controlled, parallel-group comparative study -
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the possibility that influencing the intestinal and oral environment and nutritional status through food intake may lead to the alleviation and improvement of menstrual-related complaints in young women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Conditions (DRSP, MDQ, PSQ)
Key secondary outcomes
Secondary outcomes:
Mood state, bacterial flora, physiologically active substances, HD5, metabolites, hemoglobin, BDHQ, etc.
Safety outcomes:
Adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
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
The active food is taken for 10 weeks from the start date of the test food intake
Interventions/Control_2
Subjects will be asked to take a placebo food for 10 weeks from the start date of taking the test food intake
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Those aged 18 to 24
Those enrolled at the university
Person who has menstruation
Key exclusion criteria
People with food allergies.
Those who cannot stop taking oligosaccharides or lactobacillus / bifidobacterium supplements during the study period.
Pregnant women or those who intend to become pregnant during the study period.
Those who are participating or planning to participate in other clinical trials during the period from 4 weeks before the pre-test until the end of the intake period.
Those who are judged by the investigator to be unsuitable for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiminori |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido University Graduate School
Division name
Innate Immunity Laboratory, Faculty of Advanced Life Science
Zip code
001-0021
Address
Kita 21-jo Nishi 11-chome, Kita-ku, Sapporo, Hokkaido
TEL
011-706-9051
kiminori@sci.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Takakuwa |
Organization
Tenshi College
Division name
Department of Nutrition School of Nursing and Nutrition
Zip code
065-0013
Address
1-30, Higashi 3-chome, Kita 13-jo, Higashi-ku, Sapporo-City, Hokkaido
TEL
011-741-1051
Homepage URL
takakuwa@tenshi.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Morinaga Milk Industry Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi University Research Ethics Committee
Address
1-30, Higashi 3-chome, Kita 13-jo, Higashi-ku, Sapporo-City, Hokkaido
Tel
011-741-1051
takakuwa@tenshi.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
天使大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067667
