UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054023 |
|---|---|
| Receipt number | R000061676 |
| Scientific Title | Effects of habitual physical activity on appetite-related hormones, appetite and energy intake in older adults with under nutrition or anorexia |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/04/01 11:36:40 |
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Basic information
Public title
Effects of habitual physical activity on appetite and eating behaviour in older adults with under nutrition and anorexia
Acronym
Effects of habitual physical activity on appetite in older adults with under nutrition or anorexia
Scientific Title
Effects of habitual physical activity on appetite-related hormones, appetite and energy intake in older adults with under nutrition or anorexia
Scientific Title:Acronym
Effects of habitual physical activity on appetite and energy intake in older adults with under nutrition or anorexia
Region
| Japan |
Condition
Condition
Anorexia
Classification by specialty
| Gastroenterology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study assesses the effects of 12 weeks of physical activity practice on fasting and postprandial appetite-related hormone concentrations, appetite and energy intake in men and women aged 65 years and older with under nutrition or anorexia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite-related hormones, Subjective appetite, Reward system appetite, Energy intake (by questionnaire)
Key secondary outcomes
Biochemistry markers, Physical function, Resting metabolic rate, Gut microbiota
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
To assess the effects on fasting and postprandial appetite-related hormone concentrations, appetite and energy intake before and after a physical activity intervention.
Interventions/Control_2
To assess the effects on fasting and postprandial appetite-related hormone concentrations, appetite and energy intake before and after a control (under free-living conditions).
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age between 65 and 85 years old
2.Non-smoker
3.A participant who did not perform weight changes plus or minus 5 % in the past six - twelve months and who has no intention to weight loss during the study
4.Those with no severe back or knee pain and do not attend hospital
5.Those without dementia
6.Not suffering from diseases affecting appetite
7.Those who are not certified as requiring long-term care
Key exclusion criteria
1.Age range outside the selection criteria
2.Smoker
3.A participant who performed weight changes plus or minus 5 % in the past six - twelve months and who has an intention to weight loss during the study
4.Outpatients with severe back and knee pain
5.Those with dementia
6.Suffering from diseases affecting appetite
7.Those who are certified as requiring long-term care
Target sample size
80
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University
Name of secondary funder(s)
Waseda University
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 | 04 | Month | 02 | 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
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061676
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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