UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041912 |
|---|---|
| Receipt number | R000047840 |
| Scientific Title | Relationship between changes in nighttime sleep autonomic nervous activity and energy intake associated with the menstrual cycle. |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/10/01 14:50:15 |
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Basic information
Public title
Relationship between changes in nighttime sleep autonomic nervous activity and energy intake associated with the menstrual cycle.
Acronym
Relationship between changes in nighttime sleep autonomic nervous activity and energy intake associated with the menstrual cycle.
Scientific Title
Relationship between changes in nighttime sleep autonomic nervous activity and energy intake associated with the menstrual cycle.
Scientific Title:Acronym
Relationship between changes in nighttime sleep autonomic nervous activity and energy intake associated with the menstrual cycle.
Region
| Japan |
Condition
Condition
Healthy women with regular menstrual cycles
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will study the relationship between the changes in autonomic nervous activity during sleep at night and energy intake during the follicular and luteal phases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in nighttime sleep autonomic activity during the follicular and luteal phases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Increase energy intake during the luteal phase
Interventions/Control_2
Keep the amount of energy constant during the follicular and luteal phases
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
The women who have regular menstrual cycles and ovulation
Key exclusion criteria
The women who is pregnant or breastfeeding, taking any medication that affects sleep or the secretion of female hormones, performing intense workouts regularly, drinking alcohol regularly, or smoking.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tada |
| Middle name | |
| Last name | Yuki |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku
TEL
03-5477-2670
y3tada@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Tada |
| Middle name | |
| Last name | Yuki |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku
TEL
03-5477-2670
Homepage URL
y3tada@nodai.ac.jp
Sponsor or person
Institute
Laboratory of Public Health and Nutrition, Department of Nutritional Science, Faculty of Applied Bio-Science, Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committees at Tokyo University of Agriculture
Address
1-1-1 Sakuragaoka, Setagaya-ku
Tel
03-5477-2532
yyoshi@nodai.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
| 2020 | Year | 10 | 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
53
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047840
