UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048218 |
|---|---|
| Receipt number | R000054947 |
| Scientific Title | Relationship between eating habits and ovarian function |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/07/01 08:54:46 |
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Basic information
Public title
Effects of skipping breakfast on ovarian and vascular endothelial function in young healthy women
Acronym
Effect of Dietary Habits on Ovarian Function
Scientific Title
Relationship between eating habits and ovarian function
Scientific Title:Acronym
DHOF
Region
| Japan |
Condition
Condition
young healthy female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of increasing the frequency of breakfast consumption on estrogen secretion and improving vascular endothelial function and autonomic nervous system function in young women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Vascular endothelial function test (flow mediated dilation: FMD) during menstrual period
2.Changes in blood estrogen levels (menstrual phase, follicular phase, and luteal phase) before and after improvement of dietary habits
Key secondary outcomes
1)Height, weight, BMI
2) Autonomic nervous system function (LF, HF) during menstrual period: ECG R-R interval change
3) Brain activity measurement (Brain Index) during menstrual period: NIRS (optical topography)
4) Basal body temperature change
5) Anxiety, depression, and other 10-item questionnaire (EPDS) score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Consume breakfast daily
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy women skipping breakfast
Key exclusion criteria
nothing in particular
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Suenaga |
Organization
Yamaguchi University Graduate School
Division name
Graduate School of Medicine
Zip code
7558054
Address
1-1-1, Minamikogushi, Ube-city, Yamaguchi prefecture
TEL
0836-22-2133
hiro1204@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Suenaga |
Organization
Yamaguchi University Graduate School
Division name
Graduate School of Medicine
Zip code
7558054
Address
1-1-1, Minamikogushi, Ube-city, Yamaguchi prefecture
TEL
0836-22-2133
Homepage URL
hiro1204@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Graduate School
Address
1-1-1, Minamikogushi, Ube-city, Yamaguchi prefecture
Tel
0836-22-2007
me202@yamaguchi-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
| 2022 | Year | 07 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
