UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045625 |
|---|---|
| Receipt number | R000051818 |
| Scientific Title | Seasonal variability of eating behaviour and appetite in the elderly |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/12/22 17:18:35 |
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Basic information
Public title
Seasonal variability of eating behaviour and appetite in the elderly
Acronym
Examining seasonal variations in eating behaviour
Scientific Title
Seasonal variability of eating behaviour and appetite in the elderly
Scientific Title:Acronym
Examining seasonal variations in eating behaviour
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between appetite, body composition, and eating behavior and diet content during the summer to winter seasons, and to clarify the mechanism of malnutrition during the summer season.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutritional status and appetite
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people aged 65 and over living in Meguro-ku
Key exclusion criteria
1) Those who are unable to participate in a total of three surveys
2) Those who are taking antipsychotic or hormonal medication that may affect their appetite
3) Those who have previously suffered ill health as a result of blood sampling
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahashi |
| Middle name | |
| Last name | Masaki |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
W9-13, 2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Fujihira |
| Middle name | |
| Last name | Kyoko |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
W9-13, 2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2467
Homepage URL
fujihira.k.ac@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Institute of Technology
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
60
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will conduct dietary surveys and blood and body measurements in summer, winter and autumn in elderly people aged 65 years and over to examine the relationship between eating behaviour, diet content, appetite and body composition during summer and winter, and to clarify the mechanism of low nutrition in summer.
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051818
