UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049875 |
|---|---|
| Receipt number | R000056804 |
| Scientific Title | Relationship between lifestyle and health, including body mass index and menstruation, in young women: monitoring study |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2022/12/24 10:44:39 |
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Basic information
Public title
Relationship between lifestyle and body mass index in young women: monitoring study
Acronym
Relationship between lifestyle and body mass index in young women
Scientific Title
Relationship between lifestyle and health, including body mass index and menstruation, in young women: monitoring study
Scientific Title:Acronym
Relationship between lifestyle and health, including body mass index and menstruation, in young women: monitoring study
Region
| Japan |
Condition
Condition
Young women (BMI; underweight, standard)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By monitoring psychophysiological indices over four menstrual cycles for under and normal weight female university students under free-living condition, we aim to clarify how individual background information (awareness and lifestyle) and biological information are related to physique and health, including menstruation.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability associated with the menstrual cycle (including assessment of autonomic nervous system activity)
Key secondary outcomes
Urinary metabolites associated with the menstrual cycle (urine metabolome analysis), assessment of energy intake and nutrients (nutrient value calculation), sleep quality (simple EEG measurement and subjective questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Standard body type: Monitoring measurements during 4 menstrual cycles (daily: heart rate, activity, weight, basal body temperature, and daily life record; follicular and luteal phases: body composition, dietary record; luteal phase only: blood sampling, sleep and menstrual questionnaire; 4 times: urine collection)
One measurement during each of the four cycles (75 g oral glucose tolerance test, estimation of energy expenditure by double-labeled water method, physical fitness test, DXA measurement)
Once in each of the 4 cycles: follicular phase and luteal phase (sleep rhythm, simple electroencephalograph, continuous blood glucose measurement, continuous body temperature measurement)
Interventions/Control_2
Underweight body type: Monitoring measurements during 4 menstrual cycles (daily: heart rate, activity, weight, basal body temperature, and daily life record; follicular and luteal phases: body composition, dietary record; luteal phase only: blood sampling, sleep and menstrual questionnaire; 4 times: urine collection)
One measurement during each of the four cycles (75 g oral glucose tolerance test, estimation of energy expenditure by double-labeled water method, physical fitness test, DXA measurement)
Once in each of the 4 cycles: follicular phase and luteal phase (sleep rhythm, simple electroencephalograph, continuous blood glucose measurement, continuous body temperature measurement)
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Body mass index; <18.5 kg/m2
Body mass index; 18.5 kg/m2 <= BMI < 25.0 kg/m2
Key exclusion criteria
People who cannot comply with the conditions, people who have been diagnosed with or are currently undergoing treatment for an eating disorder, people who have been (or are) taking/using hormone preparations (e.g., pills) for the past six months, people with irregular menstruation (amenorrhea is OK), people who exercise more than five days a week, people diagnosed with lifestyle-related diseases (diabetes, hypertension, etc.), pregnant or nursing mothers, smokers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Ogata |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
hogata@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Ogata |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
Homepage URL
hogata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
Tel
0824246589
hogata@hiroshima-u.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
| 2022 | Year | 12 | Month | 22 | 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 | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 23 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056804
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| Registered date | File name |
| Research case data | |
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