UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057120 |
|---|---|
| Receipt number | R000065285 |
| Scientific Title | The relationship between the intake of 10 food groups and physical function among people living in the community. |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2025/02/24 11:36:45 |
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Basic information
Public title
The relationship between the intake of 10 food groups and physical function among people living in the community.
Acronym
The relationship between the intake of 10 food groups and physical function among people living in the community.
Scientific Title
The relationship between the intake of 10 food groups and physical function among people living in the community.
Scientific Title:Acronym
The relationship between the intake of 10 food groups and physical function among people living in the community.
Region
| Japan |
Condition
Condition
frail
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between number of foods and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary variety assessed by dietary variety score (DVS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
More than 7 items
Interventions/Control_2
Less than 7 items
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people aged 65 or older who live in the community (at home) and do not meet the exclusion criteria.
Key exclusion criteria
Those who did not give consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
TEL
0742414742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
TEL
0742414742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama University
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
Tezukayama University
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
Tel
0742414742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
06-36
Org. issuing International ID_1
Tezukayama University Research Ethics Committee
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 | 02 | Month | 26 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 27 | 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
| 2025 | Year | 02 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065285
