UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060772 |
|---|---|
| Receipt number | R000069494 |
| Scientific Title | A study on the cognitive function improvement effect of paprika xanthophyll intervention and extraocular muscle exercise |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/02/27 09:31:31 |
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Basic information
Public title
A study on the cognitive function improvement effect of paprika xanthophyll intervention and extraocular muscle exercise
Acronym
A study on the cognitive function improvement effect of paprika xanthophyll intervention and extraocular muscle exercise
Scientific Title
A study on the cognitive function improvement effect of paprika xanthophyll intervention and extraocular muscle exercise
Scientific Title:Acronym
A study on the cognitive function improvement effect of paprika xanthophyll intervention and extraocular muscle exercise
Region
| Japan |
Condition
Condition
Healthy male and female university students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the combination of test product intake and extraocular muscle exercise on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Trail Making Test-B difference
Key secondary outcomes
Stroop test difference
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test product: Soft capsule containing Paprika xanthophyll
Administration: 1 capsule per day
Interventions/Control_2
Duration: Four weeks
Test product: Paprika xanthophyll-free soft capsules
Administration: 1 capsule per day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Students enrolled in the Faculty of Human Health Sciences at Kansai University, who are 20 years of age or older and currently have no restrictions from their doctor regarding exercise or visual stimulation.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Funahashi |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
eri.funahashi@glico.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hosogi |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
Homepage URL
yumi.hosogi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Glico Nutrition Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai University, Faculty of Health and Well-being
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Glico Group Research Ethics Committee
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.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
関西大学 人間健康学部（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | 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
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069494
