UMIN-ICDS Clinical Trial

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

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

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

Primary outcomes

Macular Pigment Optical Density(MPOD)

Key secondary outcomes

Protection from light stimulation, Contrast sensitivity

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

FANCL Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Professor Hiroharu Kamioka, Tokyo University of Agriculture

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

045-226-0797

Email

gakujutsu_sdi@fancl.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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