UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046785 |
|---|---|
| Receipt number | R000052574 |
| Scientific Title | Ingestion of paprika xanthophyll supplement further enhances cognitive function improvement effect of transient multitasking exercise |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/01/31 13:53:12 |
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Basic information
Public title
Effect of paprika xanthophyll supplementation on cognitive improvement by multitask exercise: A Pilot study for middle-aged and older adults
Acronym
Effects of paprika xanthophyll supplementation on cognitive function
Scientific Title
Ingestion of paprika xanthophyll supplement further enhances cognitive function improvement effect of transient multitasking exercise
Scientific Title:Acronym
Ingestion of paprika xanthophyll supplement further enhances cognitive function improvement effect of transient multitasking exercise
Region
| Japan |
Condition
Condition
Healthy middle-aged and elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the cognitive function effects of multitasking exercise before and after ingestion of xanthophyll in middle-aged and elderly people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Trail Making Test (TMT) will be conducted for the first time and 4 weeks later.
Key secondary outcomes
Heart rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In the first experiment, the cognitive task and the chair standing exercise were performed before the exercise, and only the cognitive task was performed after the exercise. During exercise, the heart rate was measured with a wearable watch.Take paprika xanthophyll for 4 weeks,A similar test will be conducted after 4 weeks.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy middle-aged and older adults
Key exclusion criteria
People with dementia or MCI
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Asako |
| Middle name | |
| Last name | Shirai |
Organization
Osaka University of Health and Sport Sciences
Division name
Sport Education
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun
TEL
0724795041
shirai@ouhs.ac.jp
Public contact
Name of contact person
| 1st name | Asako |
| Middle name | |
| Last name | Shirai |
Organization
Kansai University Graduate Schoo
Division name
Faculty of Health and Well-being
Zip code
590-8815
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
TEL
072-229-5022
Homepage URL
shirai@ouhs.ac.jp
Sponsor or person
Institute
Kansai University Graduate School
Faculty of Health and Well-being
Institute
Department
Personal name
Funding Source
Organization
Kansai University Graduate School
Faculty of Health and Well-being
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
Kansai University Graduate School
Address
1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
Tel
072-229-5022
shirai@ouhs.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
関西大学大学院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
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
| 2020 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052574
