UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048943 |
|---|---|
| Receipt number | R000054045 |
| Scientific Title | Effects of Exercise and Nutrition Interventions on Cognitive Functioning in Elderly Individuals in the Community |
| Date of disclosure of the study information | 2022/09/17 |
| Last modified on | 2024/09/16 16:39:03 |
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Basic information
Public title
Effects of Exercise and Nutrition Interventions on Cognitive Function in the Elderly
Acronym
Exercise and Nutrition Interventions on Elderly Cognitive Function
Scientific Title
Effects of Exercise and Nutrition Interventions on Cognitive Functioning in Elderly Individuals in the Community
Scientific Title:Acronym
Exercise, Nutritional Interventions, and Cognitive Functioning in Elderly Individuals in the Community
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of exercise or peanut and rice oil ingestion on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body Composition
Cognitive function
Blood lipids (triglycerides, free fatty acids, HDL cholesterol, LDL cholesterol)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Nutrition (peanut/rice oil)/no ingestion
Interventions/Control_2
5 days per week
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese
2) Able to ingest nutrition for 5 days a week
3) Those who agree to participate in the experiment
Key exclusion criteria
Diseased person
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Morimasa |
| Middle name | |
| Last name | Kato |
Organization
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tori-machi, Yonezawa 992-0025, Yamagata, Japan
TEL
0238-22-7375
m-kato@yone.ac.jp
Public contact
Name of contact person
| 1st name | Morimasa |
| Middle name | |
| Last name | Kato |
Organization
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tori-machi, Yonezawa 992-0025, Yamagata, Japan
TEL
0238-22-7375
Homepage URL
m-kato@yone.ac.jp
Sponsor or person
Institute
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Institute
Department
Personal name
Funding Source
Organization
Denroku Co., Ltd
Sanwa Yushi Co., 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
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Address
6-15-1 Tori-machi, Yonezawa 992-0025, Yamagata, Japan
Tel
+ 81-238-22-7375
m-kato@yone.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
| 2022 | Year | 09 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054045
