UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054167
Receipt number R000061854
Scientific Title A systematic review of the function of "lutein , zeaxanthin" to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity (updated version from 2019)
Date of disclosure of the study information 2024/04/16
Last modified on 2024/04/16 12:57:08

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Basic information

Public title

A systematic review of the function of "lutein , zeaxanthin" to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity (updated version from 2019)

Acronym

A systematic review of the function of "lutein , zeaxanthin" to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity (updated version from 2019)

Scientific Title

A systematic review of the function of "lutein , zeaxanthin" to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity (updated version from 2019)

Scientific Title:Acronym

A systematic review of the function of "lutein , zeaxanthin" to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity (updated version from 2019)

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 "lutein , zeaxanthin" have the ability to increases pigment in the macular area, protects the eyes from light stimulation, and improves contrast sensitivity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Macular Pigment Optical Density(MPOD)

Key secondary outcomes

Protection from light stimulation, Contrast sensitivity


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 "lutein, zeaxanthin", with unlimited intake quantities, intake period, and follow-up period.
Studies involving interventions with a 5:1 ratio of "lutein, zeaxanthin" will be included to ensure equivalence with the final product.

C-Comparison: Comparison group
A comparison was made among one receiving a placebo, another serving as a control group in which food was substituted with food that does not contain "lutein , zeaxanthin" and group with no intervention.

O-Outcome: Evaluation items
Main outcomes: Macular Pigment Optical Density(MPOD)
Secondary outcomes: Protection from light stimulation, Contrast sensitivity

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

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3525

Email

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

045-226-0797

Homepage URL


Email

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

045-226-0797

Email

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 04 Month 16 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

2024 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2024 Year 04 Month 17 Day

Last follow-up date

2024 Year 05 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Literature search]
Search across 16 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 04 Month 16 Day

Last modified on

2024 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name