UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044505 |
|---|---|
| Receipt number | 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 | 2025/03/12 16:06:30 |
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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
| Obstetrics 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
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
aaa.agt.221@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
https://www.sciencedirect.com/science/article/pii/S2589004224029444?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2589004224029444?via%3Dihub
Number of participants that the trial has enrolled
46
Results
Energy metabolism
Results date posted
| 2025 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
General healthy male and female, Athlete
Participant flow
Observational
Adverse events
Nothing
Outcome measures
Energy metabolism
Reproductive function
Sleep stage obtained by polysomnography
Macronutrient obtained by dietary record
Body composition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050844
