UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054838 |
|---|---|
| Receipt number | R000062662 |
| Scientific Title | A systematic review of the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue (updated version from 2019) |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/07/01 15:24:56 |
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Basic information
Public title
A systematic review of the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue (updated version from 2019)
Acronym
A systematic review of the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue
Scientific Title
A systematic review of the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue (updated version from 2019)
Scientific Title:Acronym
A systematic review of the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue
Region
| Japan |
Condition
Condition
Healthy adults (those who are not suffering from any diseases, excluding those(/individuals) under 18 years old, pregnant women, and lactating women)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify whether the function of astaxanthin on maintaining eye focus adjustment and reducing eye fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Accommodation(Evaluation of the function maintains accommodation and reduces eye fatigue)
Key secondary outcomes
Other accommodative test (accommodative tension speed, accommodative relaxation speed, accommodative tension time, accommodative relaxation time)
Subjective assessment of eye fatigue (visual analogue scale (VAS), questionnaire, interview)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
P-Participant: Participant
The subjects were healthy volunteers (excluding those under 18, pregnant women, and lactating women, who were not suffering from any diseases).
I-Intervention: Intervention (food) characteristics
The intervention condition was defined as the intake of foods containing "Astaxanthin", with unlimited intake quantities, intake period, and follow-up period.
C-Comparison: Comparison group
A comparison was made among one receiving a placebo.
O-Outcome: Evaluation items
Main outcomes:
Accommodation(Evaluation of the function maintains accommodation and reduces eye fatigue)
Secondary outcomes:
Other accommodative test (accommodative tension speed, accommodative relaxation speed, accommodative tension time, accommodative relaxation time)
Subjective assessment of eye fatigue (visual analogue scale (VAS), questionnaire, interview)
S-Study design: Research design
The research designs used in the literature were randomized parallel group controlled trials (RCTPs), randomized crossover trials (RCTCOs), and quasi-randomized controlled trials (quasi-RCTs). In addition, the languages of presentation were documents written in Japanese and English. As a general rule, the presentation format will be an original paper, and papers in the form of short reports or summaries will also be accepted if the content can be specified. Abstracts of academic conference presentations (conference minutes) were excluded because their descriptive content was considered insufficient. There was no question as to whether or not the journal in which the article was published had been peer-reviewed. To avoid publication bias, we also included studies with results published in clinical trial registry databases. Regarding gray literature, we decided to use doctoral theses, reports from government agencies, think tanks, etc. whose detailed contents could be identified.
Key exclusion criteria
The literature which does not meet the key inclusion criteria will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Functional Food Research Institute
Zip code
2440806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3525
gakujutsu_sdi@fancl.co.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Katsu |
Organization
FANCL Corporation
Division name
Functional Food Research Institute
Zip code
2318528
Address
89-1, Yamashita-cho, Naka-ku, Yokohama, Kanagawa
TEL
0452261392
Homepage URL
gakujutsu_sdi@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Professor Hiroharu Kamioka, Tokyo University of Agriculture
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
045-226-1392
gakujutsu_sdi@fancl.co.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
| 2024 | Year | 07 | 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
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Literature search]Search across 14 databases. The search targets studies published from the time the site was first established or installed up to the date of each search. The search will be conducted by researcher E.
[Literature selection and data extraction]Three researchers (A,B,C) will independently screen the literature and extract data based on the eligibility criteria.
[Risk of bias in studies]Two researchers (A and B) will independently assess risk of bias and indirectness.
[Inconsistency] The agreement rate as high (-2) when it was between 50.0% and 59.9%, as medium (-1) when it was between 60.0% and 79.9%, as low(0) when it was between 80.0% and 100%.If the number of reports is only one, set it to high (-2) by default.
[Imprecision]If the total sample size of the target study is 100 or more,it is evaluated as low (0). If the total sample size is 40 or more and less than 100,it is evaluated as medium (-1). If the total sample size is less than 40,it is evaluated as high (-2).
[Meta-analysis]Regarding eligibility for meta-analysis, studies with low or medium risk of bias and no heterogeneity in PICOS will be targeted. A and B will conduct a meta-analysis using the free software RevMan5 or R.Forest plots will be used to test for heterogeneity, and funnel plots will be employed to clarify publication bias in the synthesis.
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062662
