UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061756 |
|---|---|
| Receipt number | R000059802 |
| Scientific Title | The effects of high-intensity interval exercise on gastrointestinal hormones and relationship with the menstrual cycle |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/06/01 00:46:40 |
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Basic information
Public title
Does the effect of acute high-intensity exercise on appetite-regulating hormones vary with the menstrual cycle?
Acronym
High-intensity exercise on appetite-regulating hormones in relation to the menstrual cycle
Scientific Title
The effects of high-intensity interval exercise on gastrointestinal hormones and relationship with the menstrual cycle
Scientific Title:Acronym
The effects of high-intensity intermittent exercise on gastrointestinal hormones and relationship with the menstrual cycle
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the menstrual cycle and appetite-regulating hormones dynamics after the high-intensity intermittent exercise in healthy active female by performing the cycling exercise in postprandial and comparing appetite with appetite-regulating hormones dynamics after the exercise in the follicular phase and the luteal phase of the menstrual cycle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acylated ghrelin, Glucagon-like peptide-1(GLP-1)
Key secondary outcomes
Anthropometry, subjective appetite, other blood carbohydrate parameters, and hormonal markers
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Experiments are conducted in the follicular and luteal phases of the menstrual cycle. Participants consume a standardised meal followed by sitting rest. Blood samples are taken to evaluate biochemical and hormonal markers.
Interventions/Control_2
Experiments are conducted in the follicular and luteal phases of the menstrual cycle. Participants consume a standardised meal followed by cycling. Blood samples are taken to evaluate biochemical and hormonal markers.
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
1. A participant who has normal menstrual cycle(25-38 days) and ovulation.
2. No chronic disease or injury
3. Not taking any medications and dietary supplements.
4. No smoker
5. Not taking any pill including hormonal drugs in the past six months.
6. Not pregnancy
7. A Participant who has been exercising for at least three days a week for the past year or more.
Key exclusion criteria
1. A participant who has not normal menstrual cycle(25-38 days) and no ovulation.
2. A participant who has chronic disease or injury.
3. A participant who takes medications and dietary supplements.
4. Smoker
5. Taking any pill including hormonal drugs in the past six months.
6. Pregnancy
7. A Participant who has not been exercising for at least three days a week for the past year or more.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Kamemoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagayaku, Tokyo
TEL
03-5706-1360
k-kamemoto@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Kamemoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagayaku, Tokyo
TEL
03-5706-1360
Homepage URL
k-kamemoto@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Kayoko Kamemoto
Funding Source
Organization
Public Interest Incorporated Foundation, LOTTE Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagayaku, Tokyo
Tel
03-5706-0931
rinri-shinsa@nittai.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
日本体育大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
8
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059802
