UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055491 |
|---|---|
| Receipt number | R000063395 |
| Scientific Title | Maintaining and improving higher brain function in the elderly through dietary modification |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2024/09/11 22:27:20 |
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Basic information
Public title
Maintaining and improving higher brain function in the elderly through dietary modification
Acronym
Higher brain function through dietary modification
Scientific Title
Maintaining and improving higher brain function in the elderly through dietary modification
Scientific Title:Acronym
Maintaining and improving higher brain function in the elderly through dietary modification
Region
| Japan |
Condition
Condition
Healthy order adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of dietary modification on higher brain function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic changes in cortex
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subject with dietary guidance from a dietitian
Interventions/Control_2
Subject without dietary guidance from a dietitian
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age: 65 to 95 years old in good health
(2) Gender: Japanese males and females
(3) Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent
(4) Right-handed, Must be able to chew normally and have no cognitive problems.
(5) Those who use smartphones on a daily basis and are able to operate them after the instruction.
Key exclusion criteria
1) Those with cognitive problems.
2) Those who suffer from diseases and are judged by the principal investigator to have difficulty continuing to participate in the study as a subject.
3) Those with masticatory dysfunction due to severe periodontal disease or non-fitting dentures.
4) Those who have restrictions on their daily diet or eating patterns due to systemic diseases.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | Hori |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Comprehensive Prosthodontics
Zip code
9518514
Address
5274, Gakkocho-dori 2-bancho, Chuo-ku, Niigata, 951-8514 Japan
TEL
0252272891
hori@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Hasegawa |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Comprehensive Prosthodontics
Zip code
9518514
Address
5274, Gakkocho-dori 2-bancho, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-2891
Homepage URL
cem17150@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata university
Institute
Department
Personal name
Funding Source
Organization
Niigata 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
Niigata university
Address
757 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2024 | Year | 09 | Month | 18 | 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
48
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063395
