UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057463 |
|---|---|
| Receipt number | R000065658 |
| Scientific Title | The impact of glucose tablet consumption on cognitive function in elderly residents of the community. |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/09/30 09:59:17 |
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Basic information
Public title
Investigating the Impact of Glucose-Containing Tablets on Cognitive Function in Community-Dwelling Elderly Individuals.
Acronym
Glucose Tablets and Cognitive Function in the Elderly.
Scientific Title
The impact of glucose tablet consumption on cognitive function in elderly residents of the community.
Scientific Title:Acronym
The Relationship Between Glucose Tablet Intake and Cognitive Function in Community-Dwelling Elderly Individuals.
Region
| Japan |
Condition
Condition
None in particular.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of short-term glucose intake on cognitive function through its general application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity measurement (brain rotation speed, attention, memory, stress level).
Key secondary outcomes
Roken-style activity capability index.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The cognitive function measurement day will be set at least 2 hours after meal intake, with a 15-minute seated rest period ensured at the measurement location. The baseline value (first measurement) will be on the study start date, and after one week (second measurement), participants will be divided into two groups: one consuming glucose tablet candies and the other engaging in rest only. The third measurement will take place after a one-week washout period, with a crossover design where the glucose tablet candy or rest-only interventions are swapped between groups.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly residents of the community who are employed and belong to the Silver Human Resources Center in City A.
1. Individuals who are employed at the time of obtaining consent.
2.Individuals who are able to visit the designated measurement day and undergo the measurement.
Key exclusion criteria
1.Individuals with or undergoing treatment for cognitive disorders such as dementia.
2.Individuals with food allergies (milk, gelatin).
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | MAYUMI |
| Middle name | |
| Last name | KURIYAMA |
Organization
Meiji University of Integrative Medicine
Division name
School of Nursing Science
Zip code
6290392
Address
Hiyoshi-cho,Nantan-shi,Kyoto
TEL
09060670820
ma_kuriyama@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | MAYUMI |
| Middle name | |
| Last name | KURIYAMA |
Organization
Meiji University of Integrative Medicine
Division name
School of Nursing Science
Zip code
6290392
Address
Hiyoshi-cho,Nantan-shi,Kyoto
TEL
0771721181
Homepage URL
ma_kuriyama@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
KURIYAMA MAYUMI
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mukogawa Women's University Graduate School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji University of Integrative Medicine Human Research Ethics Review Board
Address
Hiyoshi-cho,Nantan-shi,Kyoto
Tel
0771721181
sec_scie@meiji-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
| 2025 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
The duration and number of participants may be subject to change depending on the health status and willingness to continue of the participants, as well as changes in the conditions of the facility and other circumstances.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065658
