UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053352 |
|---|---|
| Receipt number | R000060894 |
| Scientific Title | Study on the effects of the combination of food ingredients and exercise on frailty |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/01/15 11:40:59 |
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Basic information
Public title
Study on the effects of the combination of food ingredients and exercise on frailty
Acronym
Study on the effects of the combination of food ingredients and exercise on frailty
Scientific Title
Study on the effects of the combination of food ingredients and exercise on frailty
Scientific Title:Acronym
Study on the effects of the combination of food ingredients and exercise on frailty
Region
| Japan |
Condition
Condition
frail
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of food ingredients on frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body composition, grasping power
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
two months intake of the test food 1
Interventions/Control_2
two months intake of the test food 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who exercises regularly
Key exclusion criteria
Participants who is currently receiving any medications or outpatient treatment.
Participants who is currently doing exercise or diet under the supervision of a doctor
Participants who is may develop allergy due to the test food
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitake |
| Middle name | |
| Last name | Baba |
Organization
ITOEN, LTD.
Division name
central research institute
Zip code
421-0516
Address
21 mekami, makinohara, shizuoka
TEL
0548-54-1247
yoshi-baba@itoen.co.jp
Public contact
Name of contact person
| 1st name | Yoshitake |
| Middle name | |
| Last name | baba |
Organization
ITOEN, LTD.
Division name
central research institute
Zip code
421-0516
Address
21 mekami, makinohara, shizuoka
TEL
0548-54-1247
Homepage URL
yoshi-baba@itoen.co.jp
Sponsor or person
Institute
ITOEN, LTD.
Institute
Department
Personal name
Funding Source
Organization
ITOEN, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
21 mekami, makinohara, shizuoka
Tel
0548-54-1247
-
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 | 01 | Month | 22 | 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
| 2023 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060894
| 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 |
