UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054104 |
|---|---|
| Receipt number | R000061789 |
| Scientific Title | Effects of dual-task exercise combined with mouth rinse and paprika xanthophyll ingestion on cognitive function |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/10/10 09:46:13 |
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Basic information
Public title
Effects of dual-task exercise combined with mouth rinse and paprika xanthophyll ingestion on cognitive function
Acronym
Effects of dual-task exercise combined with mouth rinse and paprika xanthophyll ingestion on cognitive function
Scientific Title
Effects of dual-task exercise combined with mouth rinse and paprika xanthophyll ingestion on cognitive function
Scientific Title:Acronym
Effects of dual-task exercise combined with mouth rinse and paprika xanthophyll ingestion on cognitive function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we hypothesized that by enhancing the oxygen-carrying efficiency of red blood cells through paprika xanthophyll, coupled with brain activation through dual-task exercise and carbohydrate mouth rinse, a synergistic effect could be induced, resulting in smoother oxygen supply to the brain and further enhancing cognitive function. Therefore, the objective is to elucidate the effects of paprika xanthophyll intake and dual-task exercise on cognitive function in middle-aged person.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function assessment, regional oxygen saturation, lifestyle questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Paprika xanthophyll(9mg/day)
Interventions/Control_2
Carbohydrate mouth rinse(A 6% concentration carbohydrate solution)
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
| 32 | years-old | <= |
Age-upper limit
| 68 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants is the healthy adult who living in Sakai city (32-65 years old)
Key exclusion criteria
A person who is allergic to gelatin
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | DONGHYUN |
| Middle name | |
| Last name | KIM |
Organization
Kansai university
Division name
Graduate School of Health and Well-being
Zip code
590-8515
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
TEL
072-229-5022
kdh3970@gmail.com
Public contact
Name of contact person
| 1st name | DONGHYUN |
| Middle name | |
| Last name | KIM |
Organization
Kansai university
Division name
Graduate School of Health and Well-being
Zip code
590-8515
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
TEL
072-229-5022
Homepage URL
kdh3970@gmail.com
Sponsor or person
Institute
Kansai university
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
Tel
072-229-5022
kdh3970@gmail.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
| 2024 | Year | 04 | Month | 15 | 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
40
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 | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2025 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061789
