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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047813
Receipt No. R000054513
Scientific Title The relationship between women's biological rhythms and behavioral inhibitory functions.
Date of disclosure of the study information 2022/05/20
Last modified on 2022/05/20

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Basic information
Public title The relationship between women's biological rhythms and behavioral inhibitory functions.
Acronym The relationship between women's biological rhythms and behavioral inhibitory functions.
Scientific Title The relationship between women's biological rhythms and behavioral inhibitory functions.
Scientific Title:Acronym The relationship between women's biological rhythms and behavioral inhibitory functions.
Region
Japan

Condition
Condition healthy persons
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine how the inhibitory function to food intake with the menstrual cycle and to clarify the inhibitory function-related neural activity and physiological and psychological changes involved. Based on these results, we will also attempt to predict changes in inhibitory function to food intake.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inhibitory function in menstrual, follicular, preovulation, and mid-luteal phases.
Key secondary outcomes The basal temperature immediately after waking up.
The body temperature and autonomic nervous activity during sleeping.
Inhibitory function-related neural activity, perimenstrual symptoms, eating behavior tendencies, sex steroid hormone level in menstrual, follicular, preovulation, and mid-luteal phases.

Base
Study type Interventional

Study design
Basic design Factorial
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
Other
Interventions/Control_1 324 general visual stimuli
Interventions/Control_2 324 high-calory food visual stimuli
Interventions/Control_3 324 low-calory food visual stimuli
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
30 years-old >=
Gender Female
Key inclusion criteria Healthy persons who are interested in the content of this research, and voluntarily volunteer to participate in response to the open call.
Key exclusion criteria History of neurological and psychiatric disorders
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Sato
Organization Niigata University of Health and Welfare
Division name Department of Health and Sports
Zip code 950-3198
Address 1398 shimami-cho, kita-ku, Niigata city
TEL 0252574624
Email daisuke@nuhw.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Sato
Organization Niigata University of Health and Welfare
Division name Department of Health and Sports
Zip code 950-3198
Address 1398 shimami-cho, kita-ku, Niigata city
TEL 0252574624
Homepage URL
Email daisuke@nuhw.ac.jp

Sponsor
Institute Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization Others
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Niigata University of Health and Welfare
Address 1398 shimami-cho, kita-ku, Niigata city
Tel 0252574624
Email daisuke@nuhw.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 新潟医療福祉大学(新潟県)

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 20 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 05 Month 20 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2024 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
2022 Year 05 Month 20 Day
Last modified on
2022 Year 05 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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