UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051867 |
|---|---|
| Receipt number | R000059175 |
| Scientific Title | Effects of habitual physical activity on homeostatic and reward system appetite, and eating behaviour |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2024/02/29 10:32:22 |
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Basic information
Public title
Effects of habitual physical activity on appetite and eating behaviour
Acronym
Effect of habitual physical activity on appetite
Scientific Title
Effects of habitual physical activity on homeostatic and reward system appetite, and eating behaviour
Scientific Title:Acronym
Effects of habitual physical activity on homeostatic and reward system appetite
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares homeostatic and reward system appetite, and eating behaviour between individuals with physically active and inactive in healthy young and older men.
Basic objectives2
Others
Basic objectives -Others
To compare homeostatic and reward system appetites and eating behaviour between individuals with physically active and inactive in healthy young and older men, the participants are asked to consume the test meal, and various assessment parameters are evaluated before and after the test meal, after that with an age x group comparison of the various assessment parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite-related hormones, reward system appetite, energy intake (by questionnaire).
Key secondary outcomes
Biochemical markers, Subjective appetite, Resting metabolic rate
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Age between 20 and 29 years old
2. Age between 65 and 74 years old
3. No taking any medications and dietary supplements related to hospital visits
4. Those with severe back or knee pain who do not attend hospital
5. No smoker
6. A participant who not performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study
7. Must not be the participant of others research within the research period (confirm by asking the participants directly and orally when explaining the research content
8. Those whose eating behaviour (chronic binge eating and food restriction) is undisturbed
9. A participant who can consume the test meal in the study
Key exclusion criteria
1. Age range outside the selection criteria
2. Taking medications and supplements related to hospital visits
3. Patients with severe back and knee pain
4. Smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study.
6. A participant who are scheduled to participate to others research
7. Those with disordered eating behaviour (chronic binge eating and food restriction)
8. A participant who cannot consume the test meal in the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda Univresity
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
+81429476774
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
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
+81429476774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda Univerity
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
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
| 2023 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare homeostatic and reward system appetites and eating behaviour between individuals with physically active and inactive in healthy young and older men, the participants are asked to consume the test meal, and various assessment parameters are evaluated before and after the test meal, after that with an age x group comparison of the various assessment parameters.
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059175
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
