UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059633 |
|---|---|
| Receipt number | R000068208 |
| Scientific Title | A systematic review of the functional role of bilberry-derived anthocyanins in alleviating eye fatigue. |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/04 13:45:41 |
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Basic information
Public title
A systematic review of the functional role of bilberry-derived anthocyanins in alleviating eye fatigue.
Acronym
A systematic review of the functional role of bilberry-derived anthocyanins in alleviating eye fatigue.
Scientific Title
A systematic review of the functional role of bilberry-derived anthocyanins in alleviating eye fatigue.
Scientific Title:Acronym
A systematic review of the functional role of bilberry-derived anthocyanins in alleviating eye fatigue.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the functional role of bilberry-derived anthocyanins in alleviating eye fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Relieves eye fatigue by improving the eye's accommodative function (near point distance, accommodative power, and accommodative time).
Key secondary outcomes
Effect of relieving eye fatigue based on subjective evaluations (VAS, subjective symptom questionnaires, etc.)
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
The subjects were healthy adults (those who are not suffering from any diseases, excluding those under 18 years old, pregnant women, and lactating women).
I: Intervention(food) characteristics
The intake of ingredients was equivalent to the anthocyanins derived from bilberry used in the final product. There were no restrictions on intake amount, intake period, or follow-up period.
C: Comparison group
Comparisons were made with a placebo group or a control group in which the test food was replaced with a food that did not contain bilberry-derived anthocyanins.
O: Evaluation items
Main outcomes: Relieves eye fatigue by improving the eye's accommodative function (near point distance, accommodative power, and accommodative time).
Secondary outcomes: Effect in relieving eye fatigue based on subjective evaluations (VAS, subjective symptom questionnaires, etc.).
S: Research design
The research designs used in the included literature were randomized parallel-group controlled trials (RCTPs), randomized crossover trials (RCTCOs), and quasi-randomized controlled trials (quasi-RCTs).The included studies were written in Japanese or English. In principle, the presentation format was an original paper; however, short reports or summaries were also accepted if the content was clearly specified.Abstracts from academic conference presentations (conference proceedings) were excluded due to insufficient descriptive content.
Whether or not the journal was peer-reviewed was not used as an exclusion criterion.To minimize publication bias, studies with results published in clinical trial registry databases were also included.Regarding gray literature, doctoral theses and reports from government agencies or think tanks were included if their detailed content 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 | erika |
| Middle name | |
| Last name | ono |
Organization
FANCL Corporation
Division name
Functional Food Research Institute
Zip code
244-0806
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
231-8528
Address
89-1, Yamashita-cho, Naka-ku, Yokohama, Kanagawa
TEL
045-226-1392
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
045-226-0797
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
| 2025 | Year | 11 | Month | 04 | 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
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Literature search] Search across 12 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.
[Research quality evaluation] Two researchers (A and B) will independently assess risk of bias and indirectness.
[Incosistency evaluation] The inconsistency is evaluated as high (-2) when the agreement rate is between 50.0% and 59.9%, medium (-1) when it is between 60.0% and 79.9%, and low(0) when it is between 80.0% and 100%. If the number of reports is only one, set it to high (-2) by default.If meta-analysis is possible, it will be assessed using tests of heterogeneity and I2 values.
[Evaluation of imprecision] If the total sample size of the included (synthesized) studies is 100 or more, it is rated as "precise (low (0))", if it is between 40 and 100, it is rated as "slightly imprecise (medium (-1))", and if it is less than 40, it is rated as "inprecise (high (-2))".
[Meta-analysis]If there are multiple references and no heterogeneity is detected, A and B will conduct a meta-analysis using the free software RevMan5 or EZR. 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
| 2025 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068208
