UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054625 |
|---|---|
| Receipt number | R000062417 |
| Scientific Title | Relationship between menstrual symptoms and timing of meals in young women |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2024/06/11 12:01:34 |
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Basic information
Public title
Relationship between menstrual symptoms and timing of meals
Acronym
Relationship between menstrual symptoms and timing of meals
Scientific Title
Relationship between menstrual symptoms and timing of meals in young women
Scientific Title:Acronym
Relationship between menstrual symptoms and timing of meals in young women
Region
| Japan |
Condition
Condition
Young women with menstrual symptom
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether or not meal timing intervention can improve menstrual symptoms in young women who have menstrual symptoms and have a habit of skipping breakfast.
Basic objectives2
Others
Basic objectives -Others
Chrono Nutrition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of menstrual concomitant symptoms, glucose dynamics, quality of sleep, core body temperature, heart rate variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Meal intervention over 3 menstrual cycles (breakfast intake group)
Interventions/Control_2
Meal intervention over 3 menstrual cycles (skipping breakfast group = control group)
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Who miss breakfast on a daily basis (4 or more times a week and have maintained this habit for the past year or more).
Have normal menstruation (menstrual cycle of 25-38 days)
Patients with menstrual symptoms (psychological or physical)
Key exclusion criteria
Have been diagnosed with or are currently being treated for an eating disorder
People who have been taking or using hormones or other drugs for the past six months
People who have been diagnosed with a lifestyle-related disease
Pregnant or lactating mothers
Smokers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Ogata |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
hogata@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Ogata |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
Homepage URL
hogata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
Tel
0824246589
hogata@hiroshima-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 | 06 | Month | 11 | 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
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2027 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062417
