UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050931 |
|---|---|
| Receipt number | R000058030 |
| Scientific Title | Investigation of the effects of lifestyle management app on cognitive function in middle-aged and elderly subjects. -Open Trial- |
| Date of disclosure of the study information | 2023/04/26 |
| Last modified on | 2024/04/25 10:39:30 |
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Basic information
Public title
Investigation of the effects of lifestyle management app on cognitive function in middle-aged and elderly subjects. -Open Trial-
Acronym
Investigation of the effects of lifestyle management app on cognitive function in middle-aged and elderly subjects. -Open Trial-
Scientific Title
Investigation of the effects of lifestyle management app on cognitive function in middle-aged and elderly subjects. -Open Trial-
Scientific Title:Acronym
Investigation of the effects of lifestyle management app on cognitive function in middle-aged and elderly subjects. -Open Trial-
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the lifestyle management app use for 12 week on cognitive function of middle-aged and older subjects by comparing before and after indicators related to cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NouKNOW(Digital tool for self-assessment of brain health.)
Key secondary outcomes
Cognitrax
Trail Making Test, Part A & Part B
Lifestyle questionnaire
Lyfestyle data collecter from lifestyle management app
Subjective evaluation questionnaire
Body weight, Body mass index, body composition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of the lifestyle management app
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women who are between 50 and 70 years of age at the time consent is obtained
2. Persons who are capable of changing their diet, exercise, and sleep habits in accordance with the advice from lifestyle management smartphone app
3. Persons who are aware of subjective cognitive decline or have had cognitive decline pointed out to them by others
4. Persons who have received a full explanation of the purpose and content of the clinical trial, have the capacity to consent, and have volunteered to participate the trial based on a good understanding, and have agreed to participate in the trial with written consent
Key exclusion criteria
1. Those who have a missing concentration score, memory score, or both in "NouKNOW" at the time of screening test.
2. Those who are using, or have used within 3 months, a diet management app or a service with dietary advice (personal trainer, fitness club with nutritional guidance, etc.)
3. Those who regularly receive dietary guidance from a physician, dietitian, or other healthcare provider.
4. Persons with a diagnosis of mild cognitive impairment or dementia.
5. Those receiving anti-dementia medications.
6. Patients receiving treatment for depression, cancer, liver disease, or renal disease.
7. Those with a previous or current medical history of alcohol dependence.
8. Persons who have difficulty using lifestyle management apps due to vision or bimanual disabilities.
9. Participants who are currently participating in a study that involves the ingestion of other foods or the use of medicines, or the application of cosmetics or medicines, or who will participate in other studies while participating in this study.
10. Other persons who are deemed inappropriate as trial subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Imaizumi |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute For Biosciences&Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi 210-8681, JAPAN
TEL
070-1003-6332
akira.imaizumi.2eh@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
CEO
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Toky
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
Ethics Committee of Ajinomoto Co., Inc.
Address
1-15-1,Kyobashi, Chuo-ku, Tokyo
Tel
+81-3-5250-8134
ajinomoto_irb@ajinomoto.com
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 | 04 | Month | 26 | 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
50
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 | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058030
