UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059350 |
|---|---|
| Receipt number | R000067884 |
| Scientific Title | The effects of acute aerobic exercise at varying intensities on appetite and energy intake in physically active and sedentary postmenopausal women |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 10:49:33 |
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Basic information
Public title
The effects of acute aerobic exercise at varying intensities on appetite in physically active and sedentary postmenopausal women
Acronym
Effect of habitual physical activity on appetite in older adults
Scientific Title
The effects of acute aerobic exercise at varying intensities on appetite and energy intake in physically active and sedentary postmenopausal women
Scientific Title:Acronym
Effect of contrasted levels of habitual physical activity on appetite in older adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines whether acute aerobic exercise of different intensities affects appetite and energy intake in active and inactive postmenopausal women (aged 65-80 years).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy intake
Key secondary outcomes
Food selection, Food reward, Appetite-related hormones, Subjective appetite
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
3
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Participants arrive in a fasted state and undergo body composition measurements (height, body mass and body composition). While seated at rest, heart rate monitoring, expired gas analysis, blood sampling and appetite assessment are conducted. Participants then perform 30 minutes of brisk walking at 60% of their estimated maximal oxygen uptake. Thereafter, they remain seated at rest until the end of the trial. A prescribed meal is provided 60 minutes after the start, and a buffet-style meal is offered at 180 minutes. Appetite-related hormones, subjective appetite, energy intake, food preference and number of chews are evaluated throughout the trial.
Interventions/Control_2
Participants arrive in a fasted state and undergo body composition measurements (height, body mass and body composition). While seated at rest, heart rate monitoring, expired gas analysis, blood sampling and appetite assessment are conducted. Participants then perform 30 minutes of walking at 30% of their estimated maximal oxygen uptake. Thereafter, they remain seated at rest until the end of the trial. A prescribed meal is provided 60 minutes after the start, and a buffet-style meal is offered at 180 minutes. Appetite-related hormones, subjective appetite, energy intake, food preference and number of chews are evaluated throughout the trial.
Interventions/Control_3
Participants arrive in a fasted state and undergo body composition measurements (height, body mass, and body composition). While seated at rest, heart rate monitoring, expired gas analysis, blood sampling and appetite assessment are conducted. No exercise is performed, and participants remain seated at rest for 30 minutes. They continue to rest until the end of the trial. A prescribed meal is provided 60 minutes after the start, and a buffet-style meal is offered at 180 minutes. Appetite-related hormones, subjective appetite, energy intake, food preference and number of chews are evaluated throughout the trial.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Age between 65 and 80 years old
2. Postmenopausal women
3. Non-smoker
4. Not taking any medications or supplements that require medical visits.
5. Those who have not been attended a hospital with severe back or knee pain
6. Not suffering from any illnesses that affect appetite.
7. A participant who did not experience weight changes plus or minus 5 % in the past six to twelve months and who has no intention of losing weight during the study
8. Not participating in other studies while they are participating in the present study
9. Those whose eating behaviour (chronic binge eating and food restriction) is undisturbed
10.A participant who can consume the test meal in the study4
Key exclusion criteria
1. Must not be aged between 65 and 80 years.
2. Women who have not yet reached menopause (those who are not postmenopausal).
3. Smoker
4. Subjects taking medications prescribed by a medical institution or using supplements.
5. Subjects currently receiving medical treatment for severe back pain or knee pain.
6. Subjects suffering from a disease that affects appetite (e.g., digestive disorders, endocrine disorders, psychiatric disorders, etc.).
7. Those who have gained or lost 5% or more of their body weight in the past 6 to 12 months or who plan to lose weight during the study period.
8. Those who are currently participating or plan to participate in other studies during the study period.
9. Those with disordered eating behaviour (chronic binge eating and food restriction)
10.A participant who cannot consume the meals provided within the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
187-0044
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Waseda University
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2025 | Year | 10 | Month | 09 | 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
| 2025 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067884
