UMIN-CTR Clinical Trial

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
Email	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
Email	hiro1204@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054947