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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044505
Receipt No. R000050844
Scientific Title Effects of reproductive function on energy metabolism and sleep in human
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/11

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Basic information
Public title Effects of reproductive function on energy metabolism and sleep in human
Acronym Effects of reproductive function on energy metabolism and sleep
Scientific Title Effects of reproductive function on energy metabolism and sleep in human
Scientific Title:Acronym Effects of reproductive function on energy metabolism and sleep
Region
Japan

Condition
Condition Generally healthy participants, amenorrhea and menstrual disorder
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the effect of reproductive function on energy metabolism and sleep.
Basic objectives2 Others
Basic objectives -Others The second aim of the study is to clarify relationships between reproductive function, energy metabolism, sleep and body composition.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Energy metabolism
Key secondary outcomes 1)Reproductive function
2)Sleep stage obtained by polysomnography
3)Macronutrient obtained by dietary record
4)Body composition

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy individuals aged over 18 years old
2) Individuals have not been restricted the exercise
Key exclusion criteria 1)Current medical conditions
2)Metabolic disorders
3)Smokers
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Sagayama
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8574
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-3963
Email sagayama.hiroyuki.ka@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Uchizawa
Organization University of Tsukuba
Division name Doctorial program in Sports Medicine
Zip code 305-8574
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-3963
Homepage URL
Email aaa.agt.221@gmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
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 University of Tsukuba, Faculty of Health and Sport Sciences IRB
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel +81-29-853-2571
Email hitorinri@un.tsukuba.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
2021 Year 06 Month 11 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2019 Year 08 Month 02 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2021 Year 06 Month 11 Day
Last modified on
2021 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050844

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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