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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041912
Receipt No. 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 2020/09/28

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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
Email 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
Email y3tada@nodai.ac.jp

Sponsor
Institute Laboratory of Public Health and Nutrition, Department of Nutritional Science, Faculty of Applied Bio-Science, Tokyo University of Agriculture
Institute
Department

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
Email t3tanaka@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
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
2020 Year 10 Month 01 Day
Date of IRB
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
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047840

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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