UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054863 |
|---|---|
| Receipt number | R000062651 |
| Scientific Title | Effect of contrasted levels of habitual physical activity on energy adjustment and eating behaviour in older adults |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2025/01/02 09:59:37 |
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Basic information
Public title
Effect of habitual physical activity on energy intake and eating behaviour in older adults
Acronym
Effect of habitual physical activity on appetite in older adults
Scientific Title
Effect of contrasted levels of habitual physical activity on energy adjustment and eating behaviour in older adults
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 compares energy intake adjustment and eating behaviour between individuals with physically active and inactive in healthy older women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite-related hormones, Subjective appetite, Food reward, Energy intake
Key secondary outcomes
Biochemistry/hormonal markers, Physical function, Resting metabolic rate
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 |
Interventions/Control_1
Fasting and postprandial circulating concentrations of appetite-related hormones and appetite are evaluated before and after consuming a prescribed meal. 90 minutes later, energy intake and food preference are evaluated during a buffet meal.
Interventions/Control_2
Fasting and postprandial circulating concentrations of appetite-related hormones and appetite are evaluated before and after performing a rest (no prescribed meal). 90 minutes later, energy intake and food preference are evaluated during a buffet meal.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Age between 65 and 80 years old
2. Female
3. Not taking any prescribed medications or dietary supplements
4. Those who have not been attended a hospital with severe back or knee pain
5. Non-smoker
6. 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
7. Not participating in other studies while they are participating in the present study
8. Those with no disordered eating behaviour (chronic binge eating and food restriction)
9. A participant who can consume the test meal in the study
Key exclusion criteria
1. Must not be aged between 65 and 80 years
2. Male
3. Taking prescribed medications and supplements
4. Those with severe back or knee pain
5. Smoker
6. A participant who performed weight changes plus or minus 5 % in the past six to twelve months and who has an intention of losing weight loss during the study
7. Participating in other studies while they are participating in the present study
8. Those with disordered eating behaviour (chronic binge eating and food restriction)
9. A participant who can not consume the test meal in 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
04-2947-6774
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
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
| 2024 | Year | 07 | Month | 04 | 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
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | 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
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062651
