UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056397 |
|---|---|
| Receipt number | R000064326 |
| Scientific Title | Effects of Japanese diet on menstrual symptoms in young women: A randomized controlled trial |
| Date of disclosure of the study information | 2024/12/08 |
| Last modified on | 2025/08/28 15:13:27 |
* 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
Effects of Japanese diet on menstrual symptoms in young women: A randomized controlled trial
Acronym
Effects of Japanese diet on menstrual symptoms in young women: A randomized controlled trial
Scientific Title
Effects of Japanese diet on menstrual symptoms in young women: A randomized controlled trial
Scientific Title:Acronym
Effects of Japanese diet on menstrual symptoms in young women: A randomized controlled trial
Region
| Japan |
Condition
Condition
Menstrual symptoms
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether nutritional guidance incorporating features of the Japanese diet can reduce menstrual symptoms in young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Distress Questionnaire (MDQ)
Key secondary outcomes
/Visual Analog Scale
/menstrual cycle
/amount of menstrual bleeding
/Self-care methods during menstruation
/Brief-type self-administered Diet History Questionnaire (BDHQ)
/Diagnostic Inventory of Health and Life Habit (DIHAL.2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
1) Provide nutritional guidance based on dietary guidelines, including the characteristics of the Japanese diet.
2) During the study, interviews will be conducted once a week regarding dietary content.
Interventions/Control_2
1) Provide nutritional guidance based on dietary guidelines.
2) During the study, interviews will be conducted once a week regarding dietary content.
Interventions/Control_3
1) No nutritional guidance will be provided.
2) During the study, interviews will be conducted once a week regarding dietary content.
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
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
/Japanese Female
/BMI<25
/Healthy adults
/Subjects with psychological or physical problems before or after menstruation.
Key exclusion criteria
/Food allergy
/Smokers
/Supplement or health food users
/Any other significant medical conditions
/Pregnant or possibly pregnant
/Receiving medication such as oral contraceptives or hormone replacement therapy
/Subjects who are judged to be unsuitable for this study by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Sugawara |
Organization
Jumonji University
Division name
Department of Health and Nutrition, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, Japan
TEL
048-477-0555
s-saeko@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Sugawara |
Organization
Jumonji University
Division name
Department of Health and Nutrition, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, Japan
TEL
048-477-0555
Homepage URL
s-saeko@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Jumonji University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Jumonji University
Address
2-1-28 Sugasawa, Niiza, Saitama, Japan
Tel
048-477-0555
s-saeko@jumonji-u.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
| 2024 | Year | 12 | Month | 08 | 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
15
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 | 11 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | 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
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064326
