UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038605 |
|---|---|
| Receipt number | R000043995 |
| Scientific Title | Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/05/19 09:05:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese
Acronym
Effect of nutritional programs on cognitive function and sleep quality
Scientific Title
Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese
Scientific Title:Acronym
Effect of nutritional programs on cognitive function and sleep quality
Region
| Japan |
Condition
Condition
Community dwelling older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of dietary program on the cognitive function and sleep quality in a community-dwelling older Japanese
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
Sleep quality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: nutritional program to improve dietary diversity (6 months)
Interventions/Control_2
Control group
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
Individuals who participate in the health promotion programs in Meiwa-machi, Gunma
Key exclusion criteria
Individuals who have difficulty in daily life without social support, who have dietary restriction such as dialysis treatment, and who are diagnosed as a sleep disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences
Zip code
374-0193
Address
1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma 374-0193, Japan
TEL
0276-82-9012
yoshizaki@toyo.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences
Zip code
374-0193
Address
1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma 374-0193, Japan
TEL
0276-82-9012
Homepage URL
yoshizaki@toyo.jp
Sponsor or person
Institute
Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences, Toyo University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists(B), Japan Society for the Promotion of Science, The Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo University
Address
2100, Kujirai, Kawagoe city, Saitama, 350-8585, Japan
Tel
049-239-1440
hoshi@toyo.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 | 03 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043995
