UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063627 |
|---|---|
| Receipt number | R000072820 |
| Scientific Title | Time-series fluctuations in subjective appetite and estimated energy expenditure before, during and after moderate level of exercise |
| Date of disclosure of the study information | 2026/11/14 |
| Last modified on | 2026/11/14 10:16:54 |
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Basic information
Public title
Exercise-related time-series fluctuations in subjective appetite and energy expenditure estimates derived from exhaled gas analysis
Acronym
Exercise-related fluctuations in subjective appetite and energy expenditure
Scientific Title
Time-series fluctuations in subjective appetite and estimated energy expenditure before, during and after moderate level of exercise
Scientific Title:Acronym
Time-series fluctuations in appetite and energy expenditure before, during and after exercise
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the detailed fluctuations in subjective appetite and energy metabolism (assessed via expired gas analysis) in healthy young women before, during, and after a 40-minute session of moderate-intensity exercise (heart rate=115-120 bpm).
Basic objectives2
Others
Basic objectives -Others
This study examines the relationship between changes in subjective appetite associated with exercise at a level typical for general health promotion and estimated resting energy expenditure before and after such exercise.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective appetite (time from the start of measurement): at the startof measurement (0 min), immediately before exercise (30 min), during exercise (50 min), at the end of exercise (70 min), during rest (90 min, 120 min, 150 min), immediately before a meal (180 min), and after a meal (210 min)
Key secondary outcomes
Energy expenditure estimates derived from expired gas analysis: at the start of measurement (0 min), during exercise (30-70 min), and immediately before a meal (180 min)
Heart rate during expired gas analysis: at the start of measurement (0 min), during exercise (30-70 min), and immediately before a meal (180 min)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
40-minute exercise using a cycle ergometer at moderate intensity (HR=115-120)
Interventions/Control_2
no exercise
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
The participants are healthy young women.
Key exclusion criteria
The exclusion criteria are as follows:
Individuals who are not currently receiving medication or treatment for respiratory, circulatory, or metabolic diseases, or for mental health conditions (including eating disorders), that would interfere with the performance of exercise.
Individuals who do not have any musculoskeletal injuries or impairments that would interfere with the performance of exercise.
Individuals who are non-smokers.
Individuals who are not pregnant.
Individuals who are not feeling unwell on the day of the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamanaka |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7, Taishido, Setagaya-ku, Tokyo
TEL
03-3411-7403
kentaro@swu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamanaka |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7, Taishido, Setagaya-ku, Tokyo
TEL
03-3411-7403
Homepage URL
kentaro@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Showa Women's University
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
Showa Women's University
Address
1-7, Taishido, Setagaya-ku, Tokyo
Tel
03-3411-7351
kenkyu@swu.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
| 2026 | Year | 11 | Month | 14 | 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
| 2026 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 11 | Month | 14 | Day |
Last modified on
| 2026 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072820
