UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047813 |
|---|---|
| Receipt number | 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 15:21:53 |
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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
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
daisuke@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054513
| Research Plan | |
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| 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 |
