UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050451 |
|---|---|
| Receipt number | R000057457 |
| Scientific Title | combined analysis of the effect of food components on memory function in elderly. |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2023/12/18 10:22:46 |
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Basic information
Public title
combined analysis of the effect of food components on memory function in elderly.
Acronym
combined analysis of the effect of food components on memory function in elderly.
Scientific Title
combined analysis of the effect of food components on memory function in elderly.
Scientific Title:Acronym
combined analysis of the effect of food components on memory function in elderly.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of food components on memory function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax (composite memory)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not applicable
Key exclusion criteria
Not applicable
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kaneda |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0654
Yoshihisa_Kaneda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sueyasu |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0676
Homepage URL
Toshiaki_Sueyasu@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Wellness Limited
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
Not applicable
Address
Not applicable
Tel
050-3182-0676
Toshiaki_Sueyasu@suntory.co.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
| 2023 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
combined analysis of human studies.
UMIN ID of the study for the combined analysis
UMIN000036488
UMIN000044844
Overview
For Cognitrax (composite memory, verbal memory, and visual memory), the combined analysis will be performed using the results of the analysis (mean values and other statistics) for the following populations for each test. In addition, as a sensitivity analysis, the combined analysis based on the results of subgroup analysis other than those listed below will also be performed.
Per protocol set (PPS)
Participants with cognitive decline
Since this is an combined analysis, no IRB was held. The same date as the "Date of protocol fixation" was entered in the "Date of IRB" field.
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057457
