UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045933 |
|---|---|
| Receipt number | R000052434 |
| Scientific Title | The effect of the supplementary capsule containing lutein on visual function in college student athletes |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2022/04/01 10:21:15 |
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Basic information
Public title
The effect of the supplementary capsule containing lutein on visual function in college student athletes
Acronym
The effect of lutein on visual function
Scientific Title
The effect of the supplementary capsule containing lutein on visual function in college student athletes
Scientific Title:Acronym
The effect of lutein on visual function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the daily supplementary capsule intake containing lutein on the visual function in college student athletes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinetic Visual Acuity
Key secondary outcomes
Depth Perception
Static Visual Acuity
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
The test food will be eaten for 35 days, and the visual function tests will be conducted before and after the ingestion.
Interventions/Control_2
The placebo food will be eaten for 35 days, and the visual function tests will be conducted before and after the ingestion.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
A subject who is a male college student and belongs to the sports club of the college.
A subject who is healthy and has not a food allergy and/or a drug allergy.
A subject who does not plan to change his/her vision correction method.
A subject who does/has not take/taken a drug and/or functional food which affects the test result during the current study period.
A subject who has not been participating or is planning to participate in the other study at the start of the current study.
Key exclusion criteria
A subject who cannot observe the precautions regarding the intake of other supplement, the diet and the lifestyle, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | SAWAKI |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai
TEL
0476-98-1001
ksawaki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | Kohmura |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai
TEL
0476-98-1001
Homepage URL
ykoumura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
MARGAJAPAN Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
APO PLUS STATION CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Juntendo University Faculty of Health and Sports Science
Address
1-1 Hiraka-gakuendai, Inzai
Tel
0476-98-1001
sc-gradkyomu@juntendo.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
| 2021 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052434
